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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thermometer, electronic, clinical
510(k) Number K193253
Device Name Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
Shenzhen Changkun Technology Co., Ltd.
801, 3F, B building, NO. 69, zhenbi Road
Biling Community, Pingshan District
shenzhen,  CN 518118
Applicant Contact steve li
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road
Huangpu District
guangzhou,  CN 510000
Correspondent Contact cassie lee
Regulation Number880.2910
Classification Product Code
Date Received11/18/2019
Decision Date 06/17/2020
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