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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 K222511
Device Name Oxy2Pro
Applicant
Southmedic, Inc.
50 Alliance Blvd.
Barrie,  CA L4M 5K3
Applicant Contact Christine Puddicombe
Correspondent
Southmedic, Inc.
50 Alliance Blvd.
Barrie,  CA L4M 5K3
Correspondent Contact Tish Whitehead
Regulation Number868.1400
Classification Product Code
CCK  
Date Received08/19/2022
Decision Date 11/21/2023
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
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