The following data is part of a premarket notification filed by Corscience Gmbh & Co. Kg with the FDA for Neuroamp Ii, Neuroamp Ii.5s.
| Device ID | K193159 |
| 510k Number | K193159 |
| Device Name: | NeuroAmp II, NeuroAmp II.5s |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Corscience GmbH & Co. KG Hartmannstrasse 65 Erlangen, DE 91052 |
| Contact | Stefan Bolleininger |
| Correspondent | Stefan Bolleininger Corscience GmbH & Co. KG Hartmannstrasse 65 Erlangen, DE 91052 |
| Product Code | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | HCC |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2020-12-30 |