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 | K062700 |
| 510k Number | K062700 |
| Device Name: | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
| Classification | Pump, Infusion |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Scott Pease |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2006-10-26 |
| Summary: | summary |