K925196 is an FDA 510(k) clearance for the BARD EPIDURAL PUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on June 18, 1993, 246 days after receiving the submission on October 15, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K925196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1992 |
| Decision Date | June 18, 1993 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |