The following data is part of a premarket notification filed by B. Braun Melsungen Ag with the FDA for Combitrans Monitoring Sets And Accessories.
| Device ID | K102033 |
| 510k Number | K102033 |
| Device Name: | COMBITRANS MONITORING SETS AND ACCESSORIES |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | B. BRAUN MELSUNGEN AG 901 MARCON BLVD Allentown, PA 18109 |
| Contact | Lisa Giaquinto |
| Correspondent | Lisa Giaquinto B. BRAUN MELSUNGEN AG 901 MARCON BLVD Allentown, PA 18109 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2011-04-07 |
| Summary: | summary |