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 |