Google Irregular Rhythm Notifications

Ref GA13099Model FB604

Google Irregular Rhythm Notifications (GA13099) is a device classified as Class IIa in the EU and Class II in the US made by Fitbit LLC, registered in EUDAMED on 13 Oct 2022 (Basic UDI-DI 081003885FB604RA), cleared under FDA 510(k) K212372 on 8 Apr 2022 and listed in FDA GUDID since 20 May 2026 (UDI-DI 00810028737778), active as of 22 Oct 2026.

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

CE MDR 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) K212372

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
United States	GUDID listing GUDID	Number00810028737778 UDI-DI	Date20 May 2026Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number081003885FB604RA Basic UDI-DI 00810028737778UDI-DI	Date13 Oct 2022Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK212372	Date8 Apr 2022Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 081003885FB604RA — open Devices and search for it
AccessGUDID record UDI-DI 00810028737778
FDA 510(k) database 510(k) number K212372

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 081003885FB604RA registered 13 Oct 2022 Active
FDA 510(k) K212372 decided 8 Apr 2022 Active
FDA GUDID UDI-DI 00810028737778 listed 20 May 2026 Listed

Timeline

3 dated events

8 Apr 2022 Cleared FDA 510(k) K212372
13 Oct 2022 Registered EUDAMED 081003885FB604RA
20 May 2026 Listed FDA GUDID 00810028737778

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Specification

EUDAMED · GUDID

Generic name: Cardiopulmonary physiological parameter analysis software, professional-only
Device name: Fitbit Irregular Rhythm Notifications
Model / reference: FB604, GA13099

Primary DI / UDI-DI: 00810028737778
Basic UDI-DI: 081003885FB604RA
Direct marketing DI: 00810028737778
510(k) Number: K212372
FDA product code: QDB
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: 870.2790
Special device type: Software
EU registration type: Standard device
EU market of registration: Netherlands
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

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Properties

Over-the-counter

Other properties (24, all answered No)