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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 K131243
Device Name NON-CONTACT INFRARED THERMOMETER
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
4th Floor, Jinhui Bldg, Nanhai Blvd., Nanshan District
Shenzhen, Guangdon,  CN 518052
Applicant Contact FIELD FU
Correspondent
Shenzhen Jumper Medical Equipment Co., Ltd.
4th Floor, Jinhui Bldg, Nanhai Blvd., Nanshan District
Shenzhen, Guangdon,  CN 518052
Correspondent Contact FIELD FU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/01/2013
Decision Date 11/12/2013
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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