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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 K170769
Device Name wireless thermometer
Applicant
Ech (Changzhou) Medical Instrument Co., Ltd.
#65, Huiling W. Rd. Zouqu Town
Changzhou,  CN 213144
Applicant Contact Yuan Hu
Correspondent
Mid-Link Consulting Co, Ltd.
Rm. 405, Ziguang Mansion
#341 Shangcheng Rd.
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/14/2017
Decision Date 07/26/2017
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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