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FDA 510(k)

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range

K-Number: K222197 · 2023-04-06

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2023-04-06
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2023-04-06 under approval number K222197. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range?

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K222197.

When was F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range approved by the FDA?

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range received FDA 510(k) clearance on 2023-04-06, under approval number K222197.

What company makes F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range?

F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range?

The FDA product code for F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range is BTT.

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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