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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 K122912
Device Name DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
Applicant
Hangzhou Hua'An Medical & Health Instruments Co.,
Bldg. 2, Baimiao Ind. Park
Economic Development Zone
Wuchang, Hangzhou, Zhejiang,  CN 310023
Applicant Contact AHNEO YANG
Correspondent
Hangzhou Hua'An Medical & Health Instruments Co.,
Bldg. 2, Baimiao Ind. Park
Economic Development Zone
Wuchang, Hangzhou, Zhejiang,  CN 310023
Correspondent Contact AHNEO YANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/21/2012
Decision Date 11/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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