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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 K000520
Device Name C-IT
Applicant
BREGAS AB
ULVSUNDAVAGEN 178B
BROMMA,  SE SE-16867
Applicant Contact PAUL KRILL
Correspondent
BREGAS AB
ULVSUNDAVAGEN 178B
BROMMA,  SE SE-16867
Correspondent Contact PAUL KRILL
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/16/2000
Decision Date 05/16/2000
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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