FDA.reportPublic FDA data

Google ECG App

Primary DI
00810028737815
Brand
Google ECG App
Company
Fitbit LLC
Model
GA13098
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QDAElectrocardiograph Software For Over-The-Counter Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDAElectrocardiograph Software For Over-The-Counter UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200948000Fitbit ECG AppFitbit, Inc.2020-09-11QDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028737815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028737815008100287378158100287378150810028737815

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis software, professional-onlyA software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.

Regulatory Flags#

DUNS number
829454672
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028737778Google Irregular Rhythm NotificationsGA13099 2026-05-20
00810038852720 Fitbit Irregular Rhythm NotificationsFB604FB6042022-04-25
00810038851983Fitbit ECG AppFB6032020-10-07
00810073612327Body Temperature Sensing SoftwareFB611FB6112025-09-16
00810073612334Loss of Pulse DetectionFB612FB6122025-09-16
00898628002038AriaFB201WFB201W2016-10-21
00898628002045AriaFB201BFB201B2016-10-21
00816137020800Aria 2 Wi-Fi Smart Scale FB202FB202BK2017-10-25
00816137020831Aria 2 Wi-Fi Smart Scale FB202 FB202WT2017-10-25
00810351028895AriaFB201B2FB201B22016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012964819WHOOP ECG FeatureWhoop, Inc.QDA2025-06-10
08806094948233Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDA2025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDA2025-06-10
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDA2023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDA2023-10-23
00860009117709Garmin ECG AppGarmin International, Inc.QDA2023-01-24
00860009117716Garmin ECG AppGarmin International, Inc.QDA2023-01-24
B210AC0210KardiaMobile CardAlivecor, Inc.QDA2022-07-13
08806092938823ECG Monitor AppSamsung Electronics Co., Ltd.QDA2021-08-25
00190199649286ECG 2.0 AppAPPLE INC.QDA2020-12-15
00190199649293ECG 2.0 AppAPPLE INC.QDA2020-12-15
00810038851983Fitbit ECG AppFitbit LLCQDA2020-10-07
08806090792021ECG Monitor AppSamsung Electronics Co., Ltd.QDA2020-09-24
08806090792045ECG Monitor AppSamsung Electronics Co., Ltd.QDA2020-09-24
B210AC0190KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+Alivecor, Inc.QDA2020-05-01
00612479249455McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249486McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249516McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249547McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249578McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249608McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249639McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249660McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249462McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249493McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249523McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249554McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249585McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249615McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249677McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22