The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Disposable Catheter Pressure Transducer.
Device ID | K874165 |
510k Number | K874165 |
Device Name: | DISPOSABLE CATHETER PRESSURE TRANSDUCER |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | Cleary |
Correspondent | Cleary DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-13 |
Decision Date | 1988-06-09 |