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FDA 510(k)

Fitbit Irregular Rhythm Notifications

K-Number: K212372 · 2022-04-08

ApplicantFitbit, Inc.
Decision Date2022-04-08
Product CodeQDB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fitbit Irregular Rhythm Notifications is a medical device manufactured by Fitbit, Inc.. It received FDA 510(k) clearance on 2022-04-08 under approval number K212372. 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 Fitbit Irregular Rhythm Notifications?

Fitbit Irregular Rhythm Notifications is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Fitbit, Inc.. The 510(k) number is K212372.

When was Fitbit Irregular Rhythm Notifications approved by the FDA?

Fitbit Irregular Rhythm Notifications received FDA 510(k) clearance on 2022-04-08, under approval number K212372.

What company makes Fitbit Irregular Rhythm Notifications?

Fitbit Irregular Rhythm Notifications is manufactured by Fitbit, Inc..

What is the FDA product code for Fitbit Irregular Rhythm Notifications?

The FDA product code for Fitbit Irregular Rhythm Notifications 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 NCT06135740 Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults COMPLETED

Other Devices by Fitbit, Inc.

K200948Fitbit ECG App

Related Devices (Code: QDB)

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