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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 K072635
Device Name CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1
Applicant
Ningbo Huahui Medical Instruments Co., Ltd.
Suite 8d, # 19 Lane 999
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Ningbo Huahui Medical Instruments Co., Ltd.
Suite 8d, # 19 Lane 999
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/18/2007
Decision Date 01/17/2008
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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