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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 K954402
Device Name ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
Applicant
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Applicant Contact ANDRAS GEDEON
Correspondent
Icor AB
Ulvsundavagen 178 B
Bromma,  SE 161 30
Correspondent Contact ANDRAS GEDEON
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/20/1995
Decision Date 05/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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