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FDA 510(k)

F&P 950 Respiratory Humidifier

K-Number: K220703 · 2023-06-16

ApplicantFisher & Paykel Healthcare
Decision Date2023-06-16
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P 950 Respiratory Humidifier is a medical device manufactured by Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2023-06-16 under approval number K220703. 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 950 Respiratory Humidifier?

F&P 950 Respiratory Humidifier is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Fisher & Paykel Healthcare. The 510(k) number is K220703.

When was F&P 950 Respiratory Humidifier approved by the FDA?

F&P 950 Respiratory Humidifier received FDA 510(k) clearance on 2023-06-16, under approval number K220703.

What company makes F&P 950 Respiratory Humidifier?

F&P 950 Respiratory Humidifier is manufactured by Fisher & Paykel Healthcare.

What is the FDA product code for F&P 950 Respiratory Humidifier?

The FDA product code for F&P 950 Respiratory Humidifier is BTT.

Related Clinical Trials

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED

Other Devices by Fisher & Paykel Healthcare

K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit K162553AirSpiral Heated Breathing Tube K221338F&P Airvo 3 K222292F&P myAirvo 3

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.

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