The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perfusor Space Infusion Syringe Pump System.
| Device ID | K092313 |
| 510k Number | K092313 |
| Device Name: | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
| Classification | Pump, Infusion, Pca |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Susan Olinger |
| Correspondent | Tracy Maddock B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-30 |
| Decision Date | 2009-11-04 |
| Summary: | summary |