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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K031124
Device Name POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
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 Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   CCL  
Date Received04/08/2003
Decision Date 12/04/2003
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
Recalls CDRH Recalls
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