NON-CONTACT CLINICAL THERMOMETER


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

Correspodent Contact james huang
Regulation Number 880.2910
Classification Product Code
FLL  
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