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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K060254
Device Name MODIFICATION TO INFINITY EXPLORER
Applicant
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact KAREN A IORIO
Correspondent
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact KAREN A IORIO
Regulation Number870.2300
Classification Product Code
MSX  
Date Received02/01/2006
Decision Date 04/04/2006
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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