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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 K221800
Device Name Infrared Thermometer (Model: Y20001, Y20002)
Applicant
Zhangzhou Easepal Medical Science and Technology Co., Ltd.
West Of The 4th Floor, # 7 Bldg., Easepal Factory,
# 228 Jiaosong Rd., Jiaomei Town
Zhangzhou,  CN 0596
Applicant Contact Flower Flower
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden, Tianhe District
Guangzhou,  CN 020
Correspondent Contact Jet Li
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/21/2022
Decision Date 12/14/2022
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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