| Device Classification Name |
Continuous Measurement Thermometer
|
| 510(k) Number |
K844056 |
| Device Name |
THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM |
| Applicant |
| Sensortek, Inc. |
| 154 Huron Ave. |
|
Clifton,
NJ
07013
|
|
| Applicant Contact |
RONALD R FELLER |
| Correspondent |
| Sensortek, Inc. |
| 154 Huron Ave. |
|
Clifton,
NJ
07013
|
|
| Correspondent Contact |
RONALD R FELLER |
| Regulation Number | 880.2910 |
| Classification Product Code |
|
| Date Received | 10/18/1984 |
| Decision Date | 01/09/1985 |
| 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
|
|
|