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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 K220084
Device Name Infrared Forehead Thermometer
Applicant
Qingdao Yasee Medical Device Co., Ltd.
No.9 Xiuyuan Road, High-tech Industrial Development Zone
Qingdao,  CN 266112
Applicant Contact Shaoju Tian
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/10/2022
Decision Date 09/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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