F&P Evora Full Face Mask
K-Number: K212371 · 2022-03-18
ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2022-03-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P Evora Full Face Mask is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-03-18 under approval number K212371. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the F&P Evora Full Face Mask?
F&P Evora Full Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K212371.
When was F&P Evora Full Face Mask approved by the FDA?
F&P Evora Full Face Mask received FDA 510(k) clearance on 2022-03-18, under approval number K212371.
What company makes F&P Evora Full Face Mask?
F&P Evora Full Face Mask is manufactured by Fisher & Paykel Healthcare, Ltd..
What is the FDA product code for F&P Evora Full Face Mask?
The FDA product code for F&P Evora Full Face Mask is BZD.
Other Devices by Fisher & Paykel Healthcare, Ltd.
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K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
Related Devices (Code: BZD)
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.