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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
Recalls CDRH Recalls
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