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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 K103604
Device Name ISA CO2, ISA AX+, ISA OR+
Applicant
Phasein AB
4213 Winnequah Dr.
Madison,  WI  53716
Applicant Contact DAVID WEISSBURG
Correspondent
Phasein AB
4213 Winnequah Dr.
Madison,  WI  53716
Correspondent Contact DAVID WEISSBURG
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/09/2010
Decision Date 04/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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