The following data is part of a premarket notification filed by Neuroscience, Inc. with the FDA for Neuroscience Map-10 Eeg.
| Device ID | K850430 |
| 510k Number | K850430 |
| Device Name: | NEUROSCIENCE MAP-10 EEG |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | NEUROSCIENCE, INC. 4916 EL CAMINO REAL Los Altos, CA 94022 |
| Contact | Anthony Depalma |
| Correspondent | Anthony Depalma NEUROSCIENCE, INC. 4916 EL CAMINO REAL Los Altos, CA 94022 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-04 |
| Decision Date | 1985-07-17 |