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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 K033894
Device Name PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032
Applicant
Matsushita Electric Works, Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Matsushita Electric Works, Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/16/2003
Decision Date 03/11/2004
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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