FDA 510(k)

IRNF App

K-Number: K212516 · 2021-10-22

Decision Date2021-10-22

Product CodeQDB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IRNF App is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K212516. 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 IRNF App?

IRNF App is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Apple, Inc.. The 510(k) number is K212516.

When did IRNF App receive FDA 510(k) clearance?

IRNF App received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212516.

Who is the listed applicant for IRNF App?

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 IRNF App?

The FDA product code for IRNF App is QDB.

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)K231173Irregular Rhythm Notification Feature (IRNF)

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Related Devices (Code: QDB)

K231173Irregular Rhythm Notification Feature (IRNF)Apple, Inc.K213971Atrial Fibrillation History FeatureApple, Inc.K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc.

Official Source

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