FDA.reportPublic FDA data

ECG App

Primary DI
00190198909541
Brand
ECG App
Company
APPLE INC.
Model
Feature Version 1.x
Published
2019-01-14
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
DEN180044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180044000ECG AppApple, Inc.2018-09-11QDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190198909541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190198909541001901989095411901989095410190198909541

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology application softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060704780
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195950591545Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00195950591552Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00190199649286ECG 2.0 AppFeature Version 2.x2020-12-15
00190199649293ECG 2.0 AppFeature Version 2.x2020-12-15
00190198909534ECG AppFeature Version 1.x2019-01-14
00195949001789Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949001796Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949948411Digital Prism Correction Feature (DPCF)Feature version 1.X2025-09-11
00195950732382Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732399Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732405Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732412Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195949149931Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00194253312512Cycle Tracking 4.0Feature Version 4.x2024-11-01
00194253312529Cycle Tracking 4.0Feature Version 4.x2024-11-01
00195949149924Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195949149948Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195949149955Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195950095067Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195950095074Hearing Aid Feature (HAF)Feature version 1.X2024-10-21

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
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