Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K030324 |
Device Name |
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES |
Applicant |
RADIANT INNOVATION, INC. |
NO. 40 LANE 19, BADE RD. |
HSINCHU CITY,
TW
300
|
|
Applicant Contact |
CHARLES CHANG |
Correspondent |
RADIANT INNOVATION, INC. |
NO. 40 LANE 19, BADE RD. |
HSINCHU CITY,
TW
300
|
|
Correspondent Contact |
CHARLES CHANG |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 01/31/2003 |
Decision Date | 02/27/2003 |
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
|
|
|