K062699 is an FDA 510(k) clearance for the PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on October 26, 2006, 45 days after receiving the submission on September 11, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K062699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2006 |
| Decision Date | October 26, 2006 |
| Days to Decision | 45 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 |