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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K100941
Device Name INFINITY MCABLE - MAINSTREAM CO2
Applicant
DRAEGER MEDICAL AG & CO. KG
53/55 MOISLINGER ALLEE
LUEBECK,  DE D-23542
Applicant Contact ULRICH SCHROEDER
Correspondent
DRAEGER MEDICAL AG & CO. KG
53/55 MOISLINGER ALLEE
LUEBECK,  DE D-23542
Correspondent Contact ULRICH SCHROEDER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/05/2010
Decision Date 04/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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