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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 K153149
Device Name Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
Applicant
Sejoy Electronics & Instruments Co., Ltd.
Bldg. 2, # 202, Zhenzhong Rd.
West Lake Economy & Technology Zone
Hang Zhou,  CN 310030
Applicant Contact Ren Yunhua
Correspondent
Sejoy Electronics & Instruments Co., Ltd.
Bldg. 2, # 202, Zhenzhong Rd.
West Lake Economy & Technology Zone
Hang Zhou,  CN 310030
Correspondent Contact Ren Yunhua
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/30/2015
Decision Date 05/27/2016
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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