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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, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K071165
Device Name ISCALERT SENSOR SYSTEM
Applicant
Alertis Medical AS
6470 Riverview Terrace
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Alertis Medical AS
6470 Riverview Terrace
Findley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number868.1150
Classification Product Code
CCC  
Date Received04/26/2007
Decision Date 11/07/2007
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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