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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 K120430
Device Name MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
Applicant
Microlife Intellectual Property GmbH
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN GOLDSTEIN-FALK
Correspondent
Microlife Intellectual Property GmbH
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN GOLDSTEIN-FALK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/13/2012
Decision Date 08/02/2012
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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