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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 K063167
Device Name EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)
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 Received10/18/2006
Decision Date 02/06/2007
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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