The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Infusomat Space Volumetric Infusion Pump System.
| Device ID | K083689 |
| 510k Number | K083689 |
| Device Name: | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
| Classification | Pump, Infusion |
| Applicant | B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton, TX 75006 |
| Contact | Linda Morgan |
| Correspondent | Linda Morgan B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton, TX 75006 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-07-01 |
| Summary: | summary |