The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Grass Model 15 Neurodata Amplifier System.
| Device ID | K963669 |
| 510k Number | K963669 |
| Device Name: | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM |
| Classification | Amplifier, Physiological Signal |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Steve Johnson |
| Correspondent | Steve Johnson ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1996-12-12 |
| Summary: | summary |