K983005 is an FDA 510(k) clearance for the PERFUSOR COMPACT. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by B.Braun Medical, Inc. (Carrollton, US). The FDA issued a Cleared decision on February 4, 1999, 160 days after receiving the submission on August 28, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K983005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1998 |
| Decision Date | February 04, 1999 |
| Days to Decision | 160 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 |