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Loss of Pulse Detection
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FB612
by Fitbit LLC
Identity
- Trade Name
- Loss of Pulse Detection EUDAMED
- Device Name
- Loss of Pulse Detection EUDAMED
- Model / Reference
- FB612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810073612334 EUDAMED
- Basic UDI-DI
- 081007361FB612NG EUDAMED
- Direct Marketing DI
- 00810073612334 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Loss of Pulse Detection by Fitbit LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242967 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081007361FB612NG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fitbit LLC
- EUDAMED SRN
- US-MF-000007439
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 26f1bc09-f92d-47a7-a2fb-9130d51f1775 61 fields · synced Jun 19, 2026
- FDA 510(k) K242967 1 fields · synced May 18, 2026