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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 K904789
Device Name SERIES 7000 CARBON DIOXIDE MODULE
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact SANDRA SCHICK
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact SANDRA SCHICK
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/23/1990
Decision Date 05/22/1991
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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