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 |