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Fitbit ECG App

by Fitbit LLC

510(k) K200948

Fitbit ECG App is a Class II device made by Fitbit LLC, cleared under FDA 510(k) K200948 on 11 Sep 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200948 Date11 Sep 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QDA
FDA applicant
Fitbit, Inc.
Device class
Class II
Regulation
21 CFR Part 870.2345
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Devices cleared under K200948

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K200948
UDI-DISize and differences
Fitbit ECG App FB603
Fitbit LLC
FB60300810038851983 —On the market
Google ECG App GA13098
Fitbit LLC
GA1309800810028737815 —On the market

Similar devices

Other devices filed under FDA product code QDA (Electrocardiograph Software For Over-The-Counter Use).

Other devices from Fitbit LLC

See all devices from Fitbit LLC →