Skip to content

Fitbit Irregular Rhythm Notifications FB604

by Fitbit LLC

Ref FB604

Fitbit Irregular Rhythm Notifications FB604 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 25 Apr 2022 (UDI-DI 00810038852720), 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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081003885FB604RA Basic UDI-DI 00810038852720UDI-DIDate13 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00810038852720 UDI-DI Date25 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212372 Date8 Apr 2022DecidedStatusActive

Official records

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 00810038852720 listed 25 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212372
  2. Listed FDA GUDID 00810038852720
  3. Registered EUDAMED 081003885FB604RA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Fitbit Irregular Rhythm Notifications
Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / Ref / Catalog
FB604
Primary DI / UDI-DI
00810038852720
Basic UDI-DI
081003885FB604RA
Direct marketing DI
00810038852720
510(k) Number
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
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
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.

Related devices

Category: Cardiopulmonary physiological parameter analysis software

Similar devices in this category

Other devices filed under ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES.

Other devices from Fitbit LLC

See all devices from Fitbit LLC →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (23, all answered No)