FDA.reportPublic FDA data

ECG Monitor App

Primary DI
08806092938823
Brand
ECG Monitor App
Company
Samsung Electronics Co., Ltd.
Model
v1.1
Device description
Samsung Health Monitor ECG App for Wear OS
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K201168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201168000ECG Monitor AppSamsung Electronics Co., Ltd.2020-08-04QDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806092938823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806092938823088060929388238806092938823

GMDN Terms#

Term, Definition table
TermDefinition
Patient general health self-management softwareAn Internet-based software program intended to be used on a non-medical computerized device, by a patient in a non-clinical environment, to provide general health assessment information and/or health advice through an interactive platform; it is not dedicated to a specific condition. The software is intended to collect patient information (demographics, lifestyle data, and/or symptoms) and feedback information to indicate the general health/wellness in key areas (e.g., mental, cardiovascular) and/or assist the patient in deciding the best course of action if they are unwell (e.g., see a clinician, self-treatment for minor ailments). It does not communicate with a clinician.

Regulatory Flags#

DUNS number
687967554
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094948233Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806090792021ECG Monitor Appv1.12020-09-24
08806090792045ECG Monitor Appv1.12020-09-24
08801643467098NAAuto Lung Nodule Detection2026-03-17
08806088565231NAGC85A2016-09-24
08806088582412NAGM852016-11-26
08806088773797NAGR40CW2019-06-19
08806094936872Samsung Sleep Apnea Feature (Wear OS)1.X2025-02-24
08806094936889Samsung Sleep Apnea Feature (Android OS)1.X2025-02-24
08806092938854Samsung Health Body Composition1.x2021-09-07
08806095896144NAF4343-AW2024-11-26
08806095799636NAGF85-3P2024-10-18
08806095799643NAGF85-SP2024-10-18
08806092938847Samsung Health Body Composition1.x2021-09-07
08806094744934NAF4335-AW2022-10-20
08806094458213NAS4335-AWM2022-05-04
08806094458220NAS4343-AWM2022-05-04

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
00860009117716Garmin ECG AppGarmin International, Inc.QDA2023-01-24
B210AC0210KardiaMobile CardAlivecor, Inc.QDA2022-07-13
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