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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 K183469
Device Name Microlife Digital Blood Pressure Monitor
Applicant
Microlife Intellectual Property GmbH
Espenstrasse 139
Widnau,  CH 9443
Applicant Contact Gerhard Frick
Correspondent
Mdi Consultants, Inc.
5 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Susan D. Goldstein-Falk
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/14/2018
Decision Date 03/12/2019
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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