The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Minature Pressure Transducer.
| Device ID | K834040 |
| 510k Number | K834040 |
| Device Name: | MINATURE PRESSURE TRANSDUCER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | CARBOMEDICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-02-10 |