The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Utah Pressure Transducer Calibrator Tru-cal.
Device ID | K850029 |
510k Number | K850029 |
Device Name: | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL |
Classification | Calibrator, Pressure, Gas |
Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Contact | Dean Wallace |
Correspondent | Dean Wallace UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Product Code | BXX |
CFR Regulation Number | 868.2620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-04 |
Decision Date | 1985-04-29 |