The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Eeg-acp.
| Device ID | K212325 |
| 510k Number | K212325 |
| Device Name: | EEG-acp |
| Classification | Media, Electroconductive |
| Applicant | SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, DE 97236 |
| Contact | Sabrina Forster |
| Correspondent | Timo Gehring SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, DE 97236 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-26 |
| Decision Date | 2022-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04262356159993 | K212325 | 000 |