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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 K033957
Device Name INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 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 Received12/22/2003
Decision Date 05/14/2004
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
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