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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
FRIDLEY,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
ALERTIS MEDICAL AS
6470 RIVERVIEW TERRACE
FRIDLEY,  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
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