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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 K141756
Device Name INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
Applicant
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Applicant Contact KAREN PROVENCHER
Correspondent
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Correspondent Contact KAREN PROVENCHER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/30/2014
Decision Date 12/12/2014
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
Recalls CDRH Recalls
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