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510(k) K230915

AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask by Vyaire Medical, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2024
Date Received
March 31, 2023
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

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  • K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit (September 14, 2017)

Other clearances for product code CCK

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  • 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)
  • 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)
  • K220533 — Endoscopy Oxygen Mask (November 16, 2022)