EDAN Diagnostics, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3009499478

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009499478
FEI Number
3009499478
Entity Name
EDAN Diagnostics, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
9918 Via Pasar, San Diego, CA 92126, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EDAN Diagnostics, Inc. (Owner Number: 10043671)
Owner / Operator Contact Address
9918 Via Pasar, San Diego, CA 92126, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Fetal & maternal monitor: F6 Express Fetal monitor: F2 Fetal & maternal monitor: F9 Express Fetal & maternal monitor: F6 Fetal & maternal monitor: F9 Fetal monitor: F3 Patient Monitor: iM20 Telemetry Transmitter: iT20 Patient Monitor: X10 Patient Monitor: X8 Patient Monitor: X12 Central Monitoring System: MFM-CNS Lite Central Monitoring System: MFM-CNS Patient Monitor: iX15 Patient Monitor: iX10 Patient Monitor: iX12 Holter ECG and ABP system: SA-20 Patient Monitor: RespArray Vital Signs Monitor, model: M3B Ultrasonic pocket Doppler: SonoTrax Basic Diagnostic Ultrasound System: Acclarix AX9 Patient Monitor: iM50 Patient Monitor: iM60 Patient Monitor: iM80 Patient Monitor: iM70 Holter System: SE-2003 Vital Signs Monitor, model: iM3s Patient Monitor: iM8 Ambulatory Blood Pressure Monitor: SA-10 Vital Signs Monitor, model: iM3 Vital Signs Monitor, model: M3A Vital Signs Monitor, model: M3 Patient Monitor: elite V5 Patient Monitor: elite V8 Patient Monitor: elite V6 Electrocardiograph: SE-1200 Express

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-09-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-04
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-09-04
HGL Transducer, Ultrasonic, Obstetric Obstetrics/Gynecology Class 2 884.2960 2025-09-04
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2025-09-04
DQA Oximeter Cardiovascular Class 2 870.2700 2025-09-04
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-09-04
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-09-04
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-12-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2025-09-04
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2025-09-04
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-09-04
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2025-09-04
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-09-04
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-09-04
DQA Oximeter Cardiovascular Class 2 870.2700 2025-09-04
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-09-04
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2025-09-04
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-12-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-12-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2025-12-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-12-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-12-10
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2025-12-10
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-12-10
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2025-12-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-12-10
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2025-12-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2025-12-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-12-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-12-10
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2025-12-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-04
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2025-09-04
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2025-09-04
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-12-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-12-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-12-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-12-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-12-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2025-12-10
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-12-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-12-10
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
HEP Monitor, Blood-Flow, Ultrasonic Obstetrics/Gynecology Class 2 884.2660 2025-09-04
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2025-09-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-04
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-09-04
DQA Oximeter Cardiovascular Class 2 870.2700 2025-09-04
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2025-09-04
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-09-04
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-09-04
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-09-04
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2025-09-04
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-09-04
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-09-04
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-09-04
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-09-04
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-09-04
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2025-09-04
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-09-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-04
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2025-09-04
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-09-04
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2025-09-04
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-09-04
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2025-09-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2025-12-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-12-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-12-10
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-12-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-12-10
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2025-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-08-13
DQA Oximeter Cardiovascular Class 2 870.2700 2025-08-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-08-13
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-10
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2025-12-10
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2025-12-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-12-10
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2025-12-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2025-12-10
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-12-10
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2025-12-10
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2025-12-10
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2025-12-10
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2025-12-10
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2025-12-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-12-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-12-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-12-10
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-10
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2025-12-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2025-09-04

Official Correspondent

Annie Wright

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EDAN Diagnostics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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K914092 Nihon Kohden America, Inc. BSM-2100A CONFIGURED PATIENT MONITOR 1992-05-28
K153473 Braemar Manufacturing, LLC Braemar Telemetry Patch System 2016-07-22
K151681 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor 2015-07-17
K150310 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor 2015-05-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2025 Philips North America 2
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05 General Electric Medical Systems Information Technology 2
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011 Philips Medical Systems North America Co. Phillips 2
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025 Philips North America 2
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009499478. Last updated year: 2026. Please use registration number 3009499478 when referencing this establishment in official correspondence.
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