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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 K882661
Device Name ACUMED 9000 ETCO(2) MONITOR
Applicant
Acumed Technologies, Inc.
P.O. Box 0925
Waukesha,  WI  53187
Applicant Contact DANIEL F CARSTEN
Correspondent
Acumed Technologies, Inc.
P.O. Box 0925
Waukesha,  WI  53187
Correspondent Contact DANIEL F CARSTEN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/28/1988
Decision Date 08/24/1988
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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