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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thermometer, electronic, clinical
510(k) Number K121118
Device Name FORA COMFORTSCAN EAR THERMOMETER
Original Applicant
FORA CARE INC.
3f, 5f, 6f, no.127, wugong
2nd rd., wugu township
taipei county,  TW 24888
Original Contact pinjung chen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/12/2012
Decision Date 06/15/2012
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
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