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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 K852062
Device Name SARACAP RESPIRATORY MONITOR
Applicant
ALLEGHANY INTL. MEDICAL TECHNOLOGY
897 FEE FEE RD.
ST.LOUIS,  MO  63043
Applicant Contact MICHAEL LOMBARDO
Correspondent
ALLEGHANY INTL. MEDICAL TECHNOLOGY
897 FEE FEE RD.
ST.LOUIS,  MO  63043
Correspondent Contact MICHAEL LOMBARDO
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/09/1985
Decision Date 08/06/1985
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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