The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Mikro-tip Cath. Pressure Transducer.
| Device ID | K830909 |
| 510k Number | K830909 |
| Device Name: | MIKRO-TIP CATH. PRESSURE TRANSDUCER |
| Classification | Probe, Thermodilution |
| Applicant | MILLAR INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-04-18 |