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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 K113798
Device Name INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
Applicant
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Applicant Contact BETH A ZIS
Correspondent
Draeger Medical Systems, Inc.
6 TECH DRIVE
ANDOVER,  MA  01810
Correspondent Contact BETH A ZIS
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CCK   DQA   DRT   DSK  
DXN   FLL   FLS   MLD   MSX  
Date Received12/23/2011
Decision Date 03/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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