| Device Classification Name |
Continuous Measurement Thermometer
|
| 510(k) Number |
K903501 |
| Device Name |
RADIANT TEMPERATUR INDICATOR MODEL 25E |
| Applicant |
| Medical Systems Corp. |
| 2805 S. Hwy. 89 |
|
Perry,
UT
84302
|
|
| Applicant Contact |
JOHN D ENSIGN |
| Correspondent |
| Medical Systems Corp. |
| 2805 S. Hwy. 89 |
|
Perry,
UT
84302
|
|
| Correspondent Contact |
JOHN D ENSIGN |
| Regulation Number | 880.2910 |
| Classification Product Code |
|
| Date Received | 08/03/1990 |
| Decision Date | 09/12/1990 |
| 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
|