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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 K211050
Device Name Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
Applicant
JKH HEALTH CO., LTD.
4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. Area
Shajing, Baoan
Shenzhen,  CN 518104
Applicant Contact Pu Jiang
Correspondent
JKH USA, LLC
3 Whatney, #102B
Irvine,  CA  92618
Correspondent Contact Bill Quanqin Dai
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/08/2021
Decision Date 11/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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