Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

F&P Optiflow Oxygen Kit (AA451J)

K-Number: K233821 · 2024-06-13

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2024-06-13
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Optiflow Oxygen Kit (AA451J) is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2024-06-13 under approval number K233821. 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 Oxygen Kit (AA451J)?

F&P Optiflow Oxygen Kit (AA451J) is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K233821.

When was F&P Optiflow Oxygen Kit (AA451J) approved by the FDA?

F&P Optiflow Oxygen Kit (AA451J) received FDA 510(k) clearance on 2024-06-13, under approval number K233821.

What company makes F&P Optiflow Oxygen Kit (AA451J)?

F&P Optiflow Oxygen Kit (AA451J) is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Optiflow Oxygen Kit (AA451J)?

The FDA product code for F&P Optiflow Oxygen Kit (AA451J) is BTT.

Related Clinical Trials

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT03554863 High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia COMPLETED NCT07515716 Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia NOT_YET_RECRUITING

Other Devices by Fisher & Paykel Healthcare, Ltd.

K161686F&P InfoSmart K161412F&P Brevida™ Nasal Pillows Mask K173193F&P SleepStyle K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)

View all 25 devices →

Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.

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.

↑