The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Asc-950 Ecg Amplifier.
| Device ID | K894161 |
| 510k Number | K894161 |
| Device Name: | ASC-950 ECG AMPLIFIER |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Donna Ray |
| Correspondent | Donna Ray ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-14 |
| Decision Date | 1989-08-03 |