Device Classification Name |
Continuous Measurement Thermometer
|
510(k) Number |
K852825 |
Device Name |
TMA TEMPERATURE MONITOR |
Applicant |
FERGUSON MEDICAL |
3407 BAY AVE. |
CHICO,
CA
95973 -8619
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
FERGUSON MEDICAL |
3407 BAY AVE. |
CHICO,
CA
95973 -8619
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 880.2910 |
Classification Product Code |
|
Date Received | 07/01/1985 |
Decision Date | 12/03/1985 |
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
|
|
|