The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Mikro-tip Catheter Transducer.
Device ID | K792177 |
510k Number | K792177 |
Device Name: | MILLAR MIKRO-TIP CATHETER TRANSDUCER |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | MILLAR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-30 |
Decision Date | 1979-11-15 |