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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 K043439
Device Name INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
Applicant
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact PENELOPE H GRECO
Regulation Number870.1025
Classification Product Code
MHX  
Date Received12/14/2004
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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