K901358 is an FDA 510(k) clearance for the BARD BIOPOTENTIAL AMPLIFIER II. This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on May 9, 1990, 47 days after receiving the submission on March 23, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.
| 510(k) Number | K901358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1990 |
| Decision Date | May 09, 1990 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRQ — Amplifier And Signal Conditioner, Transducer Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2060 |