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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 K083750
Device Name CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
Applicant
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact ROBERT L CASARSA
Correspondent
Ge Medical Systems Information Technologies
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact ROBERT L CASARSA
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DPS   DQA   DQK   DRT  
DSB   DSI   DXN   GWQ  
Date Received12/17/2008
Decision Date 03/23/2009
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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