The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Flow Directed Mikro-tip Pressure Transducer.
| Device ID | K935166 |
| 510k Number | K935166 |
| Device Name: | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Contact | Jonell Oliver |
| Correspondent | Jonell Oliver MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-27 |
| Decision Date | 1994-08-05 |