Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000130829

FEI Number

3000130829

Entity Name

ANALOG DEVICES

City/State/Country

Wilmington, MA, US

Establishment Address

One Analog Way, Wilmington, MA 01887, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Analog Devices (Owner Number: 10089993)

Owner / Operator Contact Address

One Analog Way, Wilmington, MA 01887, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243216

PMA Number

N/A

All Registered Proprietary Names

Sensinel CPM Base Station Sensinel CPM Mobile Application Sensinel Intelligent Algorithm Sensinel CPM Wearable Sensinel CPM Web Application Sensinel CPM System Sensinel CPM Adhesives Sensinel CPM Mobile Application Gen 1.6 Sensinel CPM Adhesives Gen 1.6 Sensinel CPM Intelligent Algorithm Gen 1.6 Sensinel CPM Wearable Gen 1.6 Sensinel CPM Base Station Gen 1.6 Sensinel CPM Web Application Gen 1.6 Sensinel CPM System Gen 1.6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2024-01-30
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2024-01-30
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-01-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-01-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-01-30
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-01-30
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2024-01-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-03-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-03-11
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2025-03-11
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-03-11
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2025-03-11
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-03-11
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2025-03-11

Official Correspondent

Sam Rajkumar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Analog Devices

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
K771506	Swartz Medical Equipment	STETHOSCOPE	1977-08-26
K082528	Noble Anesthesia-Air, Inc.	SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM	2009-03-06
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000130829. Last updated year: 2026. Please use registration number 3000130829 when referencing this establishment in official correspondence.