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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K172795
Device Name Infrared Thermometer
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
D Building, No. 71, Xintian Road, Fuyong Street, Baoan,
Shenzhen, Guangdong
Shenzhen,  CN 518102
Applicant Contact Rambo Yang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
Shizhou middle
Shenzhen,  CN gd755
Correspondent Contact Field Fu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/15/2017
Decision Date 03/14/2018
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
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