Comby EEG Caps
by PAMEL d.o.o.
510(k) K211315
Comby EEG Caps is a Class II device made by PAMEL d.o.o., cleared under FDA 510(k) K211315 on 9 Nov 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211315 | Date9 Nov 2021 | StatusActive |
Official records
- FDA 510(k) database K211315
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXY
- FDA applicant
- Pamel D.O.O
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K211315
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| COMBY EEG CAP Bypass electrodes Ag/AgCl | BYP10 / Bypass electrodes Ag/AgCl | 03858894153398 | — | On the market |
| COMBY EEG CAP Bypass electrodes Ag/AgCl, green | BYP10G / Bypass electrodes Ag/AgCl, green | 03858894153411 | — | On the market |
| COMBY EEG CAP Bypass electrodes Ag/AgCl, red | BYP10R / Bypass electrodes Ag/AgCl, red | 03858894153428 | — | On the market |
| COMBY EEG CAP Bypass electrodes Ag/AgCl, yellow | BYP10Y / Bypass electrodes Ag/AgCl, yellow | 03858894153442 | — | On the market |
| COMBY EEG CAP Chest belt for EEG cap for adults | BFRA / Chest belt for EEG cap for adults | 03858894154135 | — | On the market |
| COMBY EEG CAP Chest belt for EEG cap for adults, L | BFRA_L / Chest belt for EEG cap for adults, L | 03858894154500 | — | On the market |
| COMBY EEG CAP Chest belt for EEG cap for adults, M | BFRA_M / Chest belt for EEG cap for adults, M | 03858894154517 | — | On the market |
| COMBY EEG CAP Chest belt for EEG cap for adults, S | BFRA_S / Chest belt for EEG cap for adults, S | 03858894154524 | — | On the market |
| COMBY EEG CAP ELECUP120 - CUP Ag/AgCl electrode | ELECUP5SET120 / ELECUP120 - CUP Ag/AgCl electrode | 03858894153183 | — | On the market |
| Comby EEG Cap/ 22 Ag/AgCl EL. | CEC1224752 / Comby EEG Cap/ 22 Ag/AgCl EL. | 03858894151950 | — | On the market |
| Comby EEG Cap/ 22 Ag/AgCl EL. | CEC1225257 / Comby EEG Cap/ 22 Ag/AgCl EL. | 03858894151967 | — | On the market |
| Comby EEG Cap/ 22 Ag/AgCl EL. | CEC1225762 / Comby EEG Cap/ 22 Ag/AgCl EL. | 03858894151974 | — | On the market |
| Comby EEG Cap/ 34 Ag/AgCl EL. | CEC1344752 / Comby EEG Cap/ 34 Ag/AgCl EL. | 03858894152810 | — | On the market |
| Comby EEG Cap/ 34 Ag/AgCl EL. | CEC1345257 / Comby EEG Cap/ 34 Ag/AgCl EL. | 03858894152827 | — | On the market |
| Comby EEG Cap/ 34 Ag/AgCl EL. | CEC1345762 / Comby EEG Cap/ 34 Ag/AgCl EL. | 03858894152834 | — | On the market |
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