The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx960 Reusable Pressure Transducer.
| Device ID | K961404 |
| 510k Number | K961404 |
| Device Name: | MX960 REUSABLE PRESSURE TRANSDUCER |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | John C Toomey |
| Correspondent | John C Toomey MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1996-06-27 |
| Summary: | summary |