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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 K230075
Device Name Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
Applicant
Microlife Intellectual Property GmbH
Espenstrasse 139
Widnau,  CH 9443
Applicant Contact Ariel Wang
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/10/2023
Decision Date 06/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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