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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 K131210
Device Name ELECTRONIC THERMOMETER
Applicant
Shenzhen Pump Medical System Co., Ltd.
Keji Nan # 12 Rd., Hi-Tech Park
Shenzhen, Guangdong,  CN 518057
Applicant Contact IVY CHEN
Correspondent
Shenzhen Pump Medical System Co., Ltd.
Keji Nan # 12 Rd., Hi-Tech Park
Shenzhen, Guangdong,  CN 518057
Correspondent Contact IVY CHEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/29/2013
Decision Date 03/18/2014
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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