The following data is part of a premarket notification filed by Neuroscientific Corp. with the FDA for The Venus System.
| Device ID | K880773 |
| 510k Number | K880773 |
| Device Name: | THE VENUS SYSTEM |
| Classification | Amplifier, Physiological Signal |
| Applicant | NEUROSCIENTIFIC CORP. 139 FLORIDA ST. Farmingdale, NY 11735 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz NEUROSCIENTIFIC CORP. 139 FLORIDA ST. Farmingdale, NY 11735 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-08-18 |