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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 K014211
Device Name OXYARM CO2
Applicant
Southmedic, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46051 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
Southmedic, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46051 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/21/2001
Decision Date 06/11/2002
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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