The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Infusomat Space Volumetric Infusion Pump.
| Device ID | K142596 |
| 510k Number | K142596 |
| Device Name: | Infusomat Space Volumetric Infusion Pump |
| Classification | Pump, Infusion |
| Applicant | B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2015-06-18 |
| Summary: | summary |