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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
Lubeck,  DE D-23542
Applicant Contact ULRICH SCHROEDER
Correspondent
Draeger Medical AG & Co. KG
53/55 Moislinger Allee
Lubeck,  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
Predetermined Change
Control Plan Authorized		 No
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