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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 K904863
Device Name MGA-IR SIDESTREAM PCO2 MODULE
Applicant
MARQUETTE GAS ANALYSIS CORP.
2383 SCHUETZ RD.
ST. LOUIS,  MO  63146
Applicant Contact JOSEPH M STYER
Correspondent
MARQUETTE GAS ANALYSIS CORP.
2383 SCHUETZ RD.
ST. LOUIS,  MO  63146
Correspondent Contact JOSEPH M STYER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/29/1990
Decision Date 06/19/1991
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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