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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 K070566
Device Name INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
Applicant
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Applicant Contact MARK KIERAS
Correspondent
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Correspondent Contact MARK KIERAS
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/28/2007
Decision Date 06/04/2007
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
Recalls CDRH Recalls
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