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FDA 510(k)

Endure ETCO2/02 Nasal Cannula

K-Number: K213767 · 2023-09-12

ApplicantEndure Industries, Inc.
Decision Date2023-09-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Endure ETCO2/02 Nasal Cannula is a medical device manufactured by Endure Industries, Inc.. It received FDA 510(k) clearance on 2023-09-12 under approval number K213767. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endure ETCO2/02 Nasal Cannula?

Endure ETCO2/02 Nasal Cannula is a medical device that received FDA 510(k) clearance on 2023-09-12. It is manufactured by Endure Industries, Inc.. The 510(k) number is K213767.

When was Endure ETCO2/02 Nasal Cannula approved by the FDA?

Endure ETCO2/02 Nasal Cannula received FDA 510(k) clearance on 2023-09-12, under approval number K213767.

What company makes Endure ETCO2/02 Nasal Cannula?

Endure ETCO2/02 Nasal Cannula is manufactured by Endure Industries, Inc..

What is the FDA product code for Endure ETCO2/02 Nasal Cannula?

The FDA product code for Endure ETCO2/02 Nasal Cannula is CCK.

Related Clinical Trials

NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT06671015 A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure RECRUITING NCT07611903 HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP NOT_YET_RECRUITING NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT07600333 CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children NOT_YET_RECRUITING NCT07564050 Physiological Effects of Different Preoxygenation Strategies RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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