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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 K222153
Device Name Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Applicant
Microlife Intellectual Property GmbH
Espenstrasse 139
Widnau,  CH 9443
Applicant Contact Gerhard Frick
Correspondent
Mdi Consultants Inc.
55 Northen Blvd, Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/20/2022
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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