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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 K152407
Device Name Infinity Delta, Infinity Delta XL, Infinity Kappa
Applicant
Draeger Medical Sytems, Inc.
6 Tech Drive
Andover,  MA  01810
Applicant Contact Beth Zis
Correspondent
Draeger Medical Sytems, Inc.
6 Tech Drive
Andover,  MA  01810
Correspondent Contact Beth Zis
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/25/2015
Decision Date 09/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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