K022575 is an FDA 510(k) clearance for the PERFUSOR COMPACT WITH FM SYSTEM. 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 August 21, 2002, 19 days after receiving the submission on August 2, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K022575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2002 |
| Decision Date | August 21, 2002 |
| Days to Decision | 19 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 |