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FDA 510(k)

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)

K-Number: K234058 · 2024-08-08

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

Device Summary

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2024-08-08 under approval number K234058. 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 Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)?

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) is a medical device that received FDA 510(k) clearance on 2024-08-08. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K234058.

When was F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) approved by the FDA?

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) received FDA 510(k) clearance on 2024-08-08, under approval number K234058.

What company makes F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)?

F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)?

The FDA product code for F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) 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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