The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Infusomat Space Volumetric Infusion Pump Administration Sets.
| Device ID | K142036 |
| 510k Number | K142036 |
| Device Name: | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Tracy Maddock |
| Correspondent | Tracy Maddock B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-08-25 |
| Summary: | summary |