RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES


Device Classification Name

thermometer, electronic, clinical

510(k) Number K030324
Device Name RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
Original Applicant
RADIANT INNOVATION, INC.
no. 40 lane 19, bade rd.
hsinchu city, 

TW

300

Original Contact charles chang
Regulation Number 880.2910
Classification Product Code
FLL  
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