K904403 is an FDA 510(k) clearance for the BARD AMBULATORY PCA DRUG DELIVERY SYSTEM. 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 December 28, 1990, 94 days after receiving the submission on September 25, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K904403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1990 |
| Decision Date | December 28, 1990 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |