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FDA 510(k)

Optiflow Oxygen Kit

K-Number: K211096 · 2022-01-28

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2022-01-28
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Optiflow Oxygen Kit is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-01-28 under approval number K211096. 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 Optiflow Oxygen Kit?

Optiflow Oxygen Kit is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K211096.

When was Optiflow Oxygen Kit approved by the FDA?

Optiflow Oxygen Kit received FDA 510(k) clearance on 2022-01-28, under approval number K211096.

What company makes Optiflow Oxygen Kit?

Optiflow Oxygen Kit is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for Optiflow Oxygen Kit?

The FDA product code for Optiflow Oxygen Kit 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

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Related Devices (Code: BTT)

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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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