COMBY EEG CAP Chest belt for EEG cap for adults
by PAMEL d.o.o.
COMBY EEG CAP Chest belt for EEG cap for adults (BFRA) is a Class II device made by PAMEL d.o.o., cleared under FDA 510(k) K211315 on 9 Nov 2021 and listed in FDA GUDID since 16 Aug 2023 (UDI-DI 03858894154135), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03858894154135 | Date16 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211315 | Date9 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 03858894154135
- FDA 510(k) database K211315
Across registries
- FDA 510(k) K211315 decided 9 Nov 2021 Active
- FDA GUDID UDI-DI 03858894154135 listed 16 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K211315
- Listed FDA GUDID 03858894154135
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comby EEG Cap
- Generic name
- Analytical scalp electrode, reusable
- Model / Ref / Catalog
- Chest belt for EEG cap for adults, BFRA
- Primary DI / UDI-DI
- 03858894154135
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Analytical scalp electrode, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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