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 |