FUTUREMED AMERICA, INC.

FDA Device Registration & Listing · GRANADA HILLS, CA, US · Registration 2433214

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
2433214
FEI Number
2433214
Entity Name
FUTUREMED AMERICA, INC.
City/State/Country
GRANADA HILLS, CA, US
Establishment Address
15700 Devonshire St, GRANADA HILLS, CA 91344, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
FUTUREMED AMERICA, INC. (Owner Number: 2433214)
Owner / Operator Contact Address
15700 DEVONSHIRE ST., --, Granada Hills, CA 91344, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K953396
PMA Number
N/A

All Registered Proprietary Names

Discovery-2 Discovery-2 Spirometer Discovery Spirometer P80 ECG SpiroAnalyzer ST-250 Futuremed SpiroVision-3+ PC Based Spirometer Futuremed Spirometry Filters SpiroVision-3+ SpiroVision SV-3+ P8000-Power

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2008-12-29
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2008-12-29
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2008-12-29
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-05-02
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2025-05-02
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2016-12-06
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2024-05-08
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2008-12-29
LOS N/A N/A Class N/A N/A 2010-12-27

Official Correspondent

MICHAEL DAVIDSON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUTUREMED AMERICA, 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
K923989 Sensor Medics Corp. SENSORMEDICS MODEL 6200 AUTOBOX DL 1993-08-09
K862544 Suzuken Co., Ltd. KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH 1986-08-06
K802368 Marquette Electronics, Inc. OPTION 301 PACEMAKER EVAL. MODULE MAC-1 1981-03-04
K131503 Edan Instruments, Inc. SE-601 SERIES ELECTROCARDIOGRAPH 2014-02-25
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2022 Welch Allyn Inc Mortara 2
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012 Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China 2
ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2433214. Last updated year: 2026. Please use registration number 2433214 when referencing this establishment in official correspondence.
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