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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 K202368
Device Name Infrared Thermometer
Applicant
Shandong Bittel Intelligent Technology Co., Ltd.
#1 Rizhao N. Rd.
Rizhao,  CN 276800
Applicant Contact Cui Shi
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/19/2020
Decision Date 02/12/2021
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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