K914381 is an FDA 510(k) clearance for the HORIZON 9000/HIS OPTION AMPLIFIER. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II - Special Controls, product code DRR).
Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on January 28, 1992, 117 days after receiving the submission on October 3, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.
| 510(k) Number | K914381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1991 |
| Decision Date | January 28, 1992 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRR — Amplifier And Signal Conditioner, Biopotential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2050 |