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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 K131771
Device Name CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
Applicant
Thermomedics, Inc.
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact PAUL LIU
Correspondent
Thermomedics, Inc.
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact PAUL LIU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/17/2013
Decision Date 10/07/2013
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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