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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 K033069
Device Name DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205
Applicant
Tenghi Co., Ltd.
112 Yi-Chung E. Rd.,
Taiping City
Taichung,  TW
Applicant Contact LIN HEIAO-FENG
Correspondent
Tenghi Co., Ltd.
112 Yi-Chung E. Rd.,
Taiping City
Taichung,  TW
Correspondent Contact LIN HEIAO-FENG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/29/2003
Decision Date 10/24/2003
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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