The following data is part of a premarket notification filed by Valley Medical Research, Inc. with the FDA for Hyperthermia Sensor Accessories.
Device ID | K900048 |
510k Number | K900048 |
Device Name: | HYPERTHERMIA SENSOR ACCESSORIES |
Classification | Thermometer, Electronic, Clinical |
Applicant | VALLEY MEDICAL RESEARCH, INC. 1102 EAST RAYMOND RD. Fruits Heights, UT 84037 |
Contact | Robert Purdy |
Correspondent | Robert Purdy VALLEY MEDICAL RESEARCH, INC. 1102 EAST RAYMOND RD. Fruits Heights, UT 84037 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-03 |
Decision Date | 1990-07-02 |