K092313 is an FDA 510(k) clearance for the PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 4, 2009, 97 days after receiving the submission on July 30, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K092313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2009 |
| Decision Date | November 04, 2009 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |