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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 K952325
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 Received05/18/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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