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510(k) K014211

OXYARM CO2 by Southmedic, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2002
Date Received
December 21, 2001
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.

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  • K101953 — SMDIA-1000 (January 7, 2011)
  • 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)
  • K222511 — Oxy2Pro (November 21, 2023)
  • K213767 — Endure ETCO2/02 Nasal Cannula (September 12, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)