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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 K173194
Device Name Temperature Probe
Applicant
Orantech, Inc.
Zone#A, 4f, 1st Bld, 7th Industrial Zone
Yulv Community, Gongming
Shenzhen,  CN 518106
Applicant Contact Hsin Xiong
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
22a, Haijing Square, # 18, Taizi Rd.
Nanshan District, Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/02/2017
Decision Date 10/10/2018
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
Predetermined Change
Control Plan Authorized		 No
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