K894161 is an FDA 510(k) clearance for the ASC-950 ECG AMPLIFIER. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II - Special Controls, product code DRR).
Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on August 3, 1989, 50 days after receiving the submission on June 14, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.
| 510(k) Number | K894161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1989 |
| Decision Date | August 03, 1989 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRR — Amplifier And Signal Conditioner, Biopotential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2050 |