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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 K182597
Device Name Infrared thermometer
Applicant
Shenzhen Pango Electronic Co., Ltd.
# 25, 1st Industry Zone, Fenghuang Rd., Xikeng Village
Henggang Town
Shenzhen,  CN 518115
Applicant Contact Youjian Xie
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Chengyu Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/20/2018
Decision Date 04/03/2019
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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