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FDA 510(k)

F&P Visairo NIV Mask Range

K-Number: K203449 · 2021-04-14

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2021-04-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Visairo NIV Mask Range is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2021-04-14 under approval number K203449. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Visairo NIV Mask Range?

F&P Visairo NIV Mask Range is a medical device that received FDA 510(k) clearance on 2021-04-14. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K203449.

When was F&P Visairo NIV Mask Range approved by the FDA?

F&P Visairo NIV Mask Range received FDA 510(k) clearance on 2021-04-14, under approval number K203449.

What company makes F&P Visairo NIV Mask Range?

F&P Visairo NIV Mask Range is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Visairo NIV Mask Range?

The FDA product code for F&P Visairo NIV Mask Range is CBK.

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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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