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FDA 510(k)

IRNF App

K-Number: K212516 · 2021-10-22

ApplicantApple, Inc.
Decision Date2021-10-22
Product CodeQDB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IRNF App is a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2021-10-22 under approval 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. It is manufactured by Apple, Inc.. The 510(k) number is K212516.

When was IRNF App approved by the FDA?

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

What company makes IRNF App?

IRNF App is manufactured by Apple, Inc..

What is the FDA product code for IRNF App?

The FDA product code for IRNF App is QDB.

Other Devices by Apple, Inc.

DEN180044ECG App DEN180042Irregular Rhythm Notification Feature K201525ECG App K213971Atrial Fibrillation History Feature K231173Irregular Rhythm Notification Feature (IRNF) K242058Digital Prism Correction Feature (DPCF)

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Related Devices (Code: QDB)

DEN180042Irregular Rhythm Notification FeatureApple, Inc. K213971Atrial Fibrillation History FeatureApple, Inc. K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc. K231173Irregular Rhythm Notification Feature (IRNF)Apple, 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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