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FDA 510(k)

Irregular Rhythm Notification Feature (IRNF)

K-Number: K231173 · 2023-07-21

ApplicantApple, Inc.
Decision Date2023-07-21
Product CodeQDB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Irregular Rhythm Notification Feature (IRNF) is a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2023-07-21 under approval number K231173. The device is classified under product code QDB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Irregular Rhythm Notification Feature (IRNF)?

Irregular Rhythm Notification Feature (IRNF) is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Apple, Inc.. The 510(k) number is K231173.

When was Irregular Rhythm Notification Feature (IRNF) approved by the FDA?

Irregular Rhythm Notification Feature (IRNF) received FDA 510(k) clearance on 2023-07-21, under approval number K231173.

What company makes Irregular Rhythm Notification Feature (IRNF)?

Irregular Rhythm Notification Feature (IRNF) is manufactured by Apple, Inc..

What is the FDA product code for Irregular Rhythm Notification Feature (IRNF)?

The FDA product code for Irregular Rhythm Notification Feature (IRNF) is QDB.

Related Clinical Trials

NCT06299514 RAFT - Pace &Ablate RECRUITING NCT05229211 Tracking Atrial Fibrillation After Intensive Care Admission ACTIVE_NOT_RECRUITING NCT07582523 Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation ENROLLING_BY_INVITATION NCT01994252 Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation COMPLETED

Other Devices by Apple, Inc.

DEN180044ECG App DEN180042Irregular Rhythm Notification Feature K201525ECG App K212516IRNF App K213971Atrial Fibrillation History Feature K242058Digital Prism Correction Feature (DPCF)

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Related Devices (Code: QDB)

DEN180042Irregular Rhythm Notification FeatureApple, Inc. K212516IRNF AppApple, Inc. K213971Atrial Fibrillation History FeatureApple, Inc. K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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