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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 K860634
Device Name PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP
Applicant
Panasonic Co. Div. Matsu Elec. Corp. America
333 Meadowland Pkwy.
Secaucus,  NJ  07094
Applicant Contact ROBERT J HEATH
Correspondent
Panasonic Co. Div. Matsu Elec. Corp. America
333 Meadowland Pkwy.
Secaucus,  NJ  07094
Correspondent Contact ROBERT J HEATH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/20/1986
Decision Date 07/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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