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FDA 510(k)

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

K-Number: K212031 · 2022-04-22

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2022-04-22
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-04-22 under approval number K212031. 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 850 AirSpiral Adult NIV and NHF Circuit Kit?

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K212031.

When was F&P 850 AirSpiral Adult NIV and NHF Circuit Kit approved by the FDA?

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit received FDA 510(k) clearance on 2022-04-22, under approval number K212031.

What company makes F&P 850 AirSpiral Adult NIV and NHF Circuit Kit?

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P 850 AirSpiral Adult NIV and NHF Circuit Kit?

The FDA product code for F&P 850 AirSpiral Adult NIV and NHF Circuit Kit is BTT.

Related Clinical Trials

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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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