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FDA 510(k)

F&P Optiflow Flow Diverter

K-Number: K234053 · 2024-08-09

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2024-08-09
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Optiflow Flow Diverter is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2024-08-09 under approval number K234053. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Optiflow Flow Diverter?

F&P Optiflow Flow Diverter is a medical device that received FDA 510(k) clearance on 2024-08-09. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K234053.

When was F&P Optiflow Flow Diverter approved by the FDA?

F&P Optiflow Flow Diverter received FDA 510(k) clearance on 2024-08-09, under approval number K234053.

What company makes F&P Optiflow Flow Diverter?

F&P Optiflow Flow Diverter is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Optiflow Flow Diverter?

The FDA product code for F&P Optiflow Flow Diverter is CBP.

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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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