FDA.reportPublic FDA data

Garmin ECG App

Primary DI
00860009117716
Brand
Garmin ECG App
Company
Garmin International, Inc.
Model
1.x
Published
2023-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009117716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009117716008600091177168600091177160860009117716

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology processing softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation and/or screening of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] or screen for specific conditions (e.g., low ejection fraction). It might include artificial intelligence (AI) and machine learning (ML) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791288004
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009117709Garmin ECG App1.x2023-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810028737815Google ECG AppFitbit LLCQDA2026-05-20
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
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