| Device Classification Name |
Continuous Measurement Thermometer
|
| 510(k) Number |
K890202 |
| Device Name |
TELE-TEMP THERMOMETER |
| Applicant |
| Rocky Mountain Medical Corp. |
| 5680 Greenwood Plz. Blvd. |
| P.O. Box 4783 |
|
Englewood,
CO
80155
|
|
| Applicant Contact |
J ROSENBAUM |
| Correspondent |
| Rocky Mountain Medical Corp. |
| 5680 Greenwood Plz. Blvd. |
| P.O. Box 4783 |
|
Englewood,
CO
80155
|
|
| Correspondent Contact |
J ROSENBAUM |
| Regulation Number | 880.2910 |
| Classification Product Code |
|
| Date Received | 01/17/1989 |
| Decision Date | 04/05/1989 |
| 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
|
|
|