Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K121428 |
Device Name |
NON-CONTACT CLINICAL THERMOMETER |
Applicant |
RADIANT INNOVATION INC. |
1F, NO.3, INDUSTRIAL E. 9TH RD |
SCIENCE-BASED INDUSTRIAL PARK |
HSINCHU,
TW
30075
|
|
Applicant Contact |
JAMES HUANG |
Correspondent |
RADIANT INNOVATION INC. |
1F, NO.3, INDUSTRIAL E. 9TH RD |
SCIENCE-BASED INDUSTRIAL PARK |
HSINCHU,
TW
30075
|
|
Correspondent Contact |
JAMES HUANG |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 05/14/2012 |
Decision Date | 07/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|