The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Somnscreenn Plus.
| Device ID | K201054 |
| 510k Number | K201054 |
| Device Name: | SOMNscreenn Plus |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | Somnomedics GmbH Am Sonnenstuhl 63 Randersacker, DE 97236 |
| Contact | Stephanie Wolski |
| Correspondent | Stefanie Wolski Somnomedics GmbH Am Sonnenstuhl 63 Randersacker, DE 97236 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2020-08-12 |