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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 K131410
Device Name CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),
Applicant
SOUTHMEDIC, INC.
50 ALLIANCE BLVD.,
BARRIE, ONTARIO,  CA L4M 5K3
Applicant Contact TISH ANGER
Correspondent
SOUTHMEDIC, INC.
50 ALLIANCE BLVD.,
BARRIE, ONTARIO,  CA L4M 5K3
Correspondent Contact TISH ANGER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/15/2013
Decision Date 01/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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