Fitbit ECG App— 510(k) K200948

Substantially Equivalent

Fitbit, Inc.

FDA 510(k) clearance K200948 for Fitbit ECG App, Substantially Equivalent on 2020-09-11. Applicant: Fitbit, Inc.. Device class: 2.

Clearance details

Applicant: Fitbit, Inc.
Product code: Code QDA
Device class: Class 2
Regulation: 21 CFR 870.2345
Advisory panel: Cardiovascular
Date received: 2020-04-08
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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