The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Mikro-tip Pulse Transducer.
| Device ID | K895721 |
| 510k Number | K895721 |
| Device Name: | MILLAR MIKRO-TIP PULSE TRANSDUCER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | MILLAR INSTRUMENTS, INC. P.O. BOX 18227 Houston, TX 77223 |
| Contact | Robert Mcnamer |
| Correspondent | Robert Mcnamer MILLAR INSTRUMENTS, INC. P.O. BOX 18227 Houston, TX 77223 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868924000236 | K895721 | 000 |