Comby EEG Cap/ 34 Ag/AgCl EL.
Comby EEG Cap/ 34 Ag/AgCl EL. (CEC1344752) is an electroencephalographic electrode cap (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 03858894152810), 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 | Number03858894152810 | Date16 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211315 | Date9 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 03858894152810
- FDA 510(k) database K211315
Across registries
- FDA 510(k) K211315 decided 9 Nov 2021 Active
- FDA GUDID UDI-DI 03858894152810 listed 16 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K211315
- Listed FDA GUDID 03858894152810
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comby EEG Cap
- Generic name
- Electroencephalographic electrode cap, reusable
- Model / Ref / Catalog
- Comby EEG Cap/ 34 Ag/AgCl EL., CEC1344752
- Primary DI / UDI-DI
- 03858894152810
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Electroencephalographic electrode cap, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
- FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE by Xi'an Friendship Medical Electronics Co., Ltd.
- Sanibel Supply A/S Gold Eartip Electrode by Interacoustics A/S
- BIOPOTENTIAL SURFACE ELECTRODE by Integral Design, Inc.
- Sense System with IBT Electrodes by Infinite Biomedical Technologies LLC
- NEURO EASE by Conmed Andover Medical, Inc.
- Myo Plus by Otto Bock Healthcare Products GmbH
- CEPTORTRODE WITH CEPTOR HESIVE by Med General
- ELECTRODE, CUTANEOUS by Cadwell Laboratories, Inc.
- TRU-PULSE PADS by Ipco Corp.
- NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE by Medicotest, Inc.