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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 K250136
Device Name Globalcare Blood Pressure Monitor (GUS610)
Applicant
Globalcare Medical Technology Co., Ltd.
#7 Factory, European Industrial Park,
# 39 Mid Industrial Main Rd. Xiaolan Town, Zhongshan City
Guangdong,  CN 528415
Applicant Contact Valentina Sassi
Correspondent
Globalcare Medical Technology Co., Ltd.
#7 Factory, European Industrial Park,
# 39 Mid Industrial Main Rd. Xiaolan Town, Zhongshan City
Guangdong,  CN 528415
Correspondent Contact Valentina Sassi
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DXQ  
Date Received01/17/2025
Decision Date 04/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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