Fitbit ECG App

Ref FB603

Fitbit ECG App (FB603) is a device classified as Class IIa in the EU and Class II in the US made by Fitbit LLC, registered in EUDAMED on 7 Feb 2022 (Basic UDI-DI B-00810038851983), cleared under FDA 510(k) K200948 on 11 Sep 2020 and listed in FDA GUDID since 7 Oct 2020 (UDI-DI 00810038851983), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200948

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00810038851983 Basic UDI-DI 00810038851983UDI-DI	Date7 Feb 2022Registered	StatusActive
United States	GUDID listing GUDID	Number00810038851983 UDI-DI	Date7 Oct 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK200948	Date11 Sep 2020Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00810038851983 — open Devices and search for it
AccessGUDID record UDI-DI 00810038851983
FDA 510(k) database 510(k) number K200948

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00810038851983 registered 7 Feb 2022 Active
FDA 510(k) K200948 decided 11 Sep 2020 Active
FDA GUDID UDI-DI 00810038851983 listed 7 Oct 2020 Listed

Timeline

3 dated events

11 Sep 2020 Cleared FDA 510(k) K200948
7 Oct 2020 Listed FDA GUDID 00810038851983
7 Feb 2022 Registered EUDAMED B-00810038851983

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name: Cardiopulmonary physiological parameter analysis software, professional-only
Model / reference: FB603

Primary DI / UDI-DI: 00810038851983
Basic UDI-DI: B-00810038851983, 081003885FB603R8
Direct marketing DI: 00810038851983
510(k) Number: K200948
FDA product code: QDA
EMDN code: Z12050382 Electrocardiographs - software accessories
GMDN term: Cardiopulmonary physiological parameter analysis software, professional-only

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 870.2345
Special device type: Software
EU registration type: Legacy device (under a directive)
Standard device
EU market of registration: Northern Ireland
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN: US-MF-000007439
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

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Properties

Over-the-counter

Other properties (24, all answered No)