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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 K890198
Device Name PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350)
Applicant
Paramed Technology, Inc.
340 Pioneer Way
Mountain View,  CA  94041
Applicant Contact LA HAYE
Correspondent
Paramed Technology, Inc.
340 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact LA HAYE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/18/1989
Decision Date 06/12/1989
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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