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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 K002727
Device Name YOUNG-HEALTH SUPER EAR THERMOMETER
Applicant
Young Health Ind. Co., Ltd.
N0.7 Nankann Shiah, Lu-Chu
Shiang
Taoyuan Hsien,  TW 338
Applicant Contact YANG RONK-JEH
Correspondent
Young Health Ind. Co., Ltd.
N0.7 Nankann Shiah, Lu-Chu
Shiang
Taoyuan Hsien,  TW 338
Correspondent Contact YANG RONK-JEH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/31/2000
Decision Date 06/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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