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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 the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2023-07-21 under 510(k) 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. The listed applicant is Apple, Inc.. The 510(k) number is K231173.

When did Irregular Rhythm Notification Feature (IRNF) receive FDA 510(k) clearance?

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

Who is the listed applicant for Irregular Rhythm Notification Feature (IRNF)?

The FDA 510(k) record lists Apple, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05298553Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac ArrhythmiasCOMPLETED

Other records listing Apple, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253582Medical Imaging Calibration Feature (MICF)K250507Hypertension Notification Feature (HTNF)K250143Digital Prism Correction Feature (DPCF)K242058Digital Prism Correction Feature (DPCF)K240929Sleep Apnea Notification Feature (SANF)K213971Atrial Fibrillation History Feature

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Related Devices (Code: QDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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