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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 K183393
Device Name Digital Thermometer
Applicant
Joytech Healthcare Co.,Ltd
No. 365 Wuzhou Road, Yuhang Economic Development Zone
Hangzhou City
Hangzhou,  CN 311100
Applicant Contact Ren Yunhua
Correspondent
Joytech Healthcare Co.,Ltd
No. 365 Wuzhou Road, Yuhang Economic Development Zone
Hangzhou City
Hangzhou,  CN 311100
Correspondent Contact Ren Yunhua
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/07/2018
Decision Date 11/18/2019
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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