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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 K031479
Device Name AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506
Applicant
DATEX-OHMEDA, INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Applicant Contact AL VAN HOUDT
Correspondent
DATEX-OHMEDA, INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Correspondent Contact AL VAN HOUDT
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/08/2003
Decision Date 06/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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