K875364 is an FDA 510(k) clearance for the MODIFIED PCA INFUSER. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 13, 1988, 105 days after receiving the submission on December 30, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K875364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1987 |
| Decision Date | April 13, 1988 |
| Days to Decision | 105 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 |