The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Pressure Monitoring Kit.
Device ID | K842352 |
510k Number | K842352 |
Device Name: | PRESSURE MONITORING KIT |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | UTAH MEDICAL PRODUCTS, INC. 1212 EAST 60 SOUTH Lehi , UT 84043 - |
Contact | Edwin O Goodman |
Correspondent | Edwin O Goodman UTAH MEDICAL PRODUCTS, INC. 1212 EAST 60 SOUTH Lehi , UT 84043 - |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-15 |
Decision Date | 1985-03-25 |