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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
Recalls CDRH Recalls
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