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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 K981542
Device Name PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
Applicant
Panasonic Corporation (Panasonic)
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact EDWARD M BASILE
Correspondent
Panasonic Corporation (Panasonic)
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact EDWARD M BASILE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/29/1998
Decision Date 03/03/1999
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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