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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 K110776
Device Name DIGITAL THERMOMETER MT SERIES
Applicant
Sejoy Electronics & Instruments Co., Ltd.
West Lake Economy & Technology
Zone
Hangzhou, Zhejiang,  CN 310030
Applicant Contact REN YUNHUA
Correspondent
Sejoy Electronics & Instruments Co., Ltd.
West Lake Economy & Technology
Zone
Hangzhou, Zhejiang,  CN 310030
Correspondent Contact REN YUNHUA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/21/2011
Decision Date 08/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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