The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Asc-954 Integrator Amplifier.
| Device ID | K896164 |
| 510k Number | K896164 |
| Device Name: | ASC-954 INTEGRATOR AMPLIFIER |
| Classification | Conditioner, Signal, Physiological |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Donna J Ray |
| Correspondent | Donna J Ray ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1990-01-22 |