| Device Classification Name |
Continuous Measurement Thermometer
|
| 510(k) Number |
K900048 |
| Device Name |
HYPERTHERMIA SENSOR ACCESSORIES |
| Applicant |
| Valley Medical Research, Inc. |
| 1102 E. Raymond Rd. |
|
Fruits Heights,
UT
84037
|
|
| Applicant Contact |
ROBERT PURDY |
| Correspondent |
| Valley Medical Research, Inc. |
| 1102 E. Raymond Rd. |
|
Fruits Heights,
UT
84037
|
|
| Correspondent Contact |
ROBERT PURDY |
| Regulation Number | 880.2910 |
| Classification Product Code |
|
| Date Received | 01/03/1990 |
| Decision Date | 07/02/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|