The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Physiological Pressure Measurement Sys.
Device ID | K830638 |
510k Number | K830638 |
Device Name: | PHYSIOLOGICAL PRESSURE MEASUREMENT SYS |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | CAMINO LABORATORIES, 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 | 1983-03-01 |
Decision Date | 1983-04-18 |