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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
Recalls CDRH Recalls
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