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Body Temperature Software
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FB611510(k) DEN230050
by Fitbit LLC
Identity
- Trade Name
- Body Temperature Software EUDAMED
- Device Name
- Body Temperature Software EUDAMED
- Model / Reference
- FB611 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810073612327 EUDAMED
- Basic UDI-DI
- 081007361FB611NE EUDAMED
- Direct Marketing DI
- 00810073612327 EUDAMED
- 510(k) Number
- DEN230050 FDA 510(k)
- FDA Product Code
- QZA FDA 510(k)
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2915 FDA 510(k)
- Regulation Number
- 880.2915 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Body Temperature Software 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 | DEN230050 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081007361FB611NE | 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 dc10d5b0-c93d-4b6c-ba1e-c9099c69ce6d 61 fields · synced Jul 15, 2026
- FDA 510(k) DEN230050 24 fields · synced May 18, 2026