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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 K030407
Device Name ADVISOR, MODEL 9200
Applicant
Bci, Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
Bci, Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/07/2003
Decision Date 08/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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