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 an analytical scalp electrode (FDA Class II; FDA product code GXY, Electrode, Cutaneous) 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- Withdrawn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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