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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 K082881
Device Name MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 NORTHERN BOULEVARD
SUITE 200
GREAT NECK,  NY  10021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 NORTHERN BOULEVARD
SUITE 200
GREAT NECK,  NY  10021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/29/2008
Decision Date 11/24/2008
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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