FDA.reportPublic FDA data

ECG Monitor App

Primary DI
08806090792045
Brand
ECG Monitor App
Company
Samsung Electronics Co., Ltd.
Model
v1.1
Published
2020-09-24
Public version status
Update
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
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
08806090792045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806090792045088060907920458806090792045

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic monitorA mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687967554
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806092938823ECG Monitor Appv1.12021-08-25
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
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
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
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