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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 K093788
Device Name INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
Applicant
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Applicant Contact CHARLES MORGANSON
Correspondent
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Correspondent Contact CHARLES MORGANSON
Regulation Number870.1025
Classification Product Code
MHX  
Date Received12/09/2009
Decision Date 03/08/2010
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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