The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Transtar Pressure Transducer.
Device ID | K942377 |
510k Number | K942377 |
Device Name: | TRANSTAR PRESSURE TRANSDUCER |
Classification | Probe, Blood-flow, Extravascular |
Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
Contact | Cathy Chenetski |
Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-18 |
Decision Date | 1994-08-16 |