The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Grass Brainwave Software.
| Device ID | K970951 |
| 510k Number | K970951 |
| Device Name: | GRASS BRAINWAVE SOFTWARE |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Stephen E Johnson |
| Correspondent | Stephen E Johnson ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-14 |
| Decision Date | 1997-05-19 |
| Summary: | summary |