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510(k) K222511

Oxy2Pro by Southmedic, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
August 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Southmedic, Inc.

  • K131410 — CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH (January 13, 2014)
  • K101953 — SMDIA-1000 (January 7, 2011)
  • K014211 — OXYARM CO2 (June 11, 2002)
  • K945993 — VAPOFIL (February 22, 1995)
  • K923265 — FUNNEL ADAPTOR (March 18, 1993)
  • K863318 — AEROSOL-T (September 11, 1986)
  • K861839 — VAPOFIL (May 21, 1986)
  • K860545 — VAPORIZER SPACER (April 17, 1986)
  • K843993 — ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 (November 15, 1984)

Other clearances for product code CCK

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  • K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (June 10, 2025)
  • K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO (June 4, 2025)
  • K240937 — AIM (N/A) (December 16, 2024)
  • K230915 — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (November 12, 2024)
  • K212425 — MicroTrend System (November 7, 2024)
  • K213767 — Endure ETCO2/02 Nasal Cannula (September 12, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)
  • K220533 — Endoscopy Oxygen Mask (November 16, 2022)