The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx900-dpt, Disposable Pressure Transducer.
Device ID | K870301 |
510k Number | K870301 |
Device Name: | MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Contact | Mark T Sondrini |
Correspondent | Mark T Sondrini MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-28 |
Decision Date | 1987-05-06 |