Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K063185 |
Device Name |
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES |
Applicant |
RADIANT INNOVATION, INC. |
1F,NO. 3,INDUSTRIAL E. 9TH RD |
SCIENCE-BASED INDUSTRIAL PARK |
HSINCHU,
TW
300
|
|
Applicant Contact |
FRANK LIN |
Correspondent |
RADIANT INNOVATION, INC. |
1F,NO. 3,INDUSTRIAL E. 9TH RD |
SCIENCE-BASED INDUSTRIAL PARK |
HSINCHU,
TW
300
|
|
Correspondent Contact |
FRANK LIN |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 10/20/2006 |
Decision Date | 11/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|