The following data is part of a premarket notification filed by Pamel D.o.o with the FDA for Comby Eeg Caps.
| Device ID | K211315 |
| 510k Number | K211315 |
| Device Name: | Comby EEG Caps |
| Classification | Electrode, Cutaneous |
| Applicant | Pamel D.o.o Mesekov Put 16 Zagreb, HR 10090 |
| Contact | Marko Pavic |
| Correspondent | Stefan Bolleininger be-on-Quality GmbH Bahnhofstrasse 85 Neunkirchen Am Sand, DE D-91233 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03858894153183 | K211315 | 000 |
| 03858894152827 | K211315 | 000 |
| 03858894152834 | K211315 | 000 |
| 03858894153398 | K211315 | 000 |
| 03858894153411 | K211315 | 000 |
| 03858894153428 | K211315 | 000 |
| 03858894153442 | K211315 | 000 |
| 03858894154135 | K211315 | 000 |
| 03858894151950 | K211315 | 000 |
| 03858894151967 | K211315 | 000 |
| 03858894151974 | K211315 | 000 |
| 03858894152810 | K211315 | 000 |