K083689 is an FDA 510(k) clearance for the INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP 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 July 1, 2009, 201 days after receiving the submission on December 12, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K083689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2008 |
| Decision Date | July 01, 2009 |
| Days to Decision | 201 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 |