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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 K182437
Device Name Wireless Intelligent Thermometer
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
D Bldg., # 71, Xintian Rd., Fuyong St., Baoan
Shenzhen,  CN 518100
Applicant Contact Tom Tom
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., L
Rm. 2012#, Gebu Commercial Bldg., Hongxing Community,
Songgang St.
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/07/2018
Decision Date 05/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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