The following data is part of a premarket notification filed by B.braun Medical Inc with the FDA for Perfusor® Space Syringe Infusion Pump System.
| Device ID | K172831 |
| 510k Number | K172831 |
| Device Name: | Perfusor® Space Syringe Infusion Pump System |
| Classification | Pump, Infusion |
| Applicant | B.Braun Medical Inc 901 Marcon Blvd Allentown, PA 18109 |
| Contact | Tracy Maddock |
| Correspondent | Tracy Maddock B.Braun Medical Inc 901 Marcon Blvd 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 | 2017-09-18 |
| Decision Date | 2018-06-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PERFUSOR 75099004 2229683 Live/Registered |
B. Braun Melsungen Aktiengesellschaft 1996-05-06 |
![]() PERFUSOR 73713157 1566970 Dead/Cancelled |
B. BRAUN MELSUNGEN AG 1988-02-24 |
![]() PERFUSOR 73533928 not registered Dead/Abandoned |
B. BRAUN MELSUNGEN AKTIENGESELLSCHAFT 1985-04-24 |