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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 K133113
Device Name KINGTECH FOREHEAD THERMOMETER
Applicant
Kingtech Enterprise, Ltd.
70 Ta Chunen Ping St., Regent Center
Rm. 2016, 20/F, Block B
Kwai Chung, New Territories,  HK HONG KONG
Applicant Contact KE MIN JEN
Correspondent
Kingtech Enterprise, Ltd.
70 Ta Chunen Ping St., Regent Center
Rm. 2016, 20/F, Block B
Kwai Chung, New Territories,  HK HONG KONG
Correspondent Contact KE MIN JEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/30/2013
Decision Date 12/26/2013
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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