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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 K203707
Device Name Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
Applicant
Shenzhen Zhengkang Technology Co., Ltd.
2&3/F, Bldg. A, #3 Fuxing Yi Lane,
Hehua Community, Pinghu St.
Shenzhen,  CN 518100
Applicant Contact Huayong Yang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Square, Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Iris Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/18/2020
Decision Date 03/12/2021
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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