Fitbit Irregular Rhythm Notifications— 510(k) K212372

Name: FDA 510(k) clearance K212372
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Substantially Equivalent

Fitbit, Inc.

FDA 510(k) clearance K212372 for Fitbit Irregular Rhythm Notifications, Substantially Equivalent on 2022-04-08. Applicant: Fitbit, Inc.. Device class: 2.

Clearance details

Applicant: Fitbit, Inc.
Product code: Code QDB
Device class: Class 2
Regulation: 21 CFR 870.2790
Advisory panel: Cardiovascular
Date received: 2021-07-30
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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DEN180042 — Irregular Rhythm Notification Feature2018-09-11

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Data sourced from openFDA. This site is unofficial and independent of the FDA.