K874441 is an FDA 510(k) clearance for the BARD BIOPOTENTIAL AMPLIFIER. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II - Special Controls, product code DRR).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 19, 1988, 83 days after receiving the submission on October 28, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.
| 510(k) Number | K874441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1987 |
| Decision Date | January 19, 1988 |
| Days to Decision | 83 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 |