The following data is part of a premarket notification filed by Neuroscience, Inc. with the FDA for Neuromapper 1620.
| Device ID | K870263 |
| 510k Number | K870263 |
| Device Name: | NEUROMAPPER 1620 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NEUROSCIENCE, INC. 210 TOPAZ ST. Milpitas, CA 95035 |
| Contact | Michael R Moran |
| Correspondent | Michael R Moran NEUROSCIENCE, INC. 210 TOPAZ ST. Milpitas, CA 95035 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-23 |
| Decision Date | 1987-04-10 |