The following data is part of a premarket notification filed by Neuroscience, Inc. with the FDA for Istat Software.
| Device ID | K871931 |
| 510k Number | K871931 |
| Device Name: | ISTAT SOFTWARE |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| 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 | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-19 |
| Decision Date | 1987-10-13 |