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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 K222160
Device Name GUS610 Blood pressure monitor
Applicant
Globalcare Medical Technology Co., Ltd.
No. 7 Factory, European Industrial Park, No. 39 Mid
Industrial Road, Xiaolan Town
Zhongshan City,  CN 528415
Applicant Contact Chiara Cavagnolo
Correspondent
Donawa Lifescience Consluting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/20/2022
Decision Date 11/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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