FDA.reportPublic FDA data

Irregular Rhythm Notifications

Primary DI
00190198909527
Brand
Irregular Rhythm Notifications
Company
APPLE INC.
Model
Feature Version 1.x
Published
2019-01-14
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
QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180042000Irregular Rhythm Notification FeatureApple, Inc.2018-09-11QDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190198909527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190198909527001901989095271901989095270190198909527

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

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
00190198909541ECG 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810028737778Google Irregular Rhythm NotificationsFitbit LLCQDB2026-05-20
08806094948233Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDB2025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDB2025-06-10
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDB2023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDB2023-10-23
00194252456798Atrial Fibrillation History FeatureAPPLE INC.QDB2022-09-12
00194252456804Atrial Fibrillation History FeatureAPPLE INC.QDB2022-09-12
00810038852720 Fitbit Irregular Rhythm NotificationsFitbit LLCQDB2022-04-25
00194252456774Irregular Rhythm Notification feature 2.0APPLE INC.QDB2022-03-14
00194252456781Irregular Rhythm Notification feature 2.0APPLE INC.QDB2022-03-14
00190198909510Irregular Rhythm NotificationsAPPLE INC.QDB2019-01-14