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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 K894693
Device Name AP-851PA NIBP MODULE
Applicant
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Applicant Contact MIKE DASHEFSKY
Correspondent
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Correspondent Contact MIKE DASHEFSKY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/24/1989
Decision Date 10/02/1989
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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