Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009715978

FEI Number

3009715978

Entity Name

AliveCor

City/State/Country

Mountain View, CA, US

Establishment Address

189 N Bernardo Avenue, Suite 100, Mountain View, CA 94043, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

AliveCor, Inc. (Owner Number: 10041430)

Owner / Operator Contact Address

189 N Bernardo Avenue, Suite 100, Mountain View, CA 94043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220196

PMA Number

N/A

All Registered Proprietary Names

KardiaAI AliveCor Heart Monitor Universal Module AliveCor Heart Monitor AliveCor Heart Monitor for Samsung Galaxy S4 AliveCor Heart Monitor Universal AliveCor ECG AliveCor Heart Monitor for iPhone AliveCor ECG for iPhone AliveCor Heart Monitor AliveCor Heart Monitor for iPhone 4/4S AliveCor Heart Monitor for iPhone 5 KardiaMobile 6L Max KardiaMobile 6L K1000 Kardia 6L+ KARDIAMOBILE Corvair KAI 12L KardiaMobile Card Kardia 6L+ KARDIAMOBILE 6L KardiaMobile 6L Max K1000 KARDIAMOBILE Kardia 12L Impala KardiaCore KardiaCore Application AliveCor Heart Monitor Kardia Mobile KardiaMobile OmronConnect KardiaBand Kardia Band OmronConnect AliveCor Heart Monitor Kardia Mobile Steth IO Spot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-03-25
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2019-06-04
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2019-06-04
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2013-10-25
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-11-27
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2022-06-24
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-06-24
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-06-24
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2019-11-01
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2019-11-01
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-06-11
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2021-12-05
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2021-12-05
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2021-12-05
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2019-06-10
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2019-06-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2019-06-10
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2015-02-02
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2015-02-02
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-06-11
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2022-06-24
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-06-24
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2022-06-24
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2015-02-02
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2015-02-02
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-11-30
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2017-11-30
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2014-08-21
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2023-10-21

Official Correspondent

Samip Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AliveCor, 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
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009715978. Last updated year: 2026. Please use registration number 3009715978 when referencing this establishment in official correspondence.