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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K222394
Device Name Electronic Sphygmomanometers
Applicant
Qingdao Yasee Medical Device Co., Ltd.
# 9 Xiuyuan Rd., High-Tech Industrial Development Zone
Qingdao,  CN 266112
Applicant Contact Shaoju Tian
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/08/2022
Decision Date 03/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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