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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K121118
Device Name FORA COMFORTSCAN EAR THERMOMETER
Applicant
Foracare, Inc.
3f, 5f, 6f, #127, Wugong
2nd Rd., Wugu Township
Taipei County,  TW 24888
Applicant Contact PINJUNG CHEN
Correspondent
Foracare, Inc.
3f, 5f, 6f, #127, Wugong
2nd Rd., Wugu Township
Taipei County,  TW 24888
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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