Home / 510(k) Clearances / K213767

510(k) K213767

Endure ETCO2/02 Nasal Cannula by Endure Industries, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2023
Date Received
December 1, 2021
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 for product code CCK

  • K250148 — Medical Gas Analyzer (AG200) (August 28, 2025)
  • 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)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)
  • K220533 — Endoscopy Oxygen Mask (November 16, 2022)