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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) 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. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K212371.

When did F&P Evora Full Face Mask receive FDA 510(k) clearance?

F&P Evora Full Face Mask received FDA 510(k) clearance on 2022-03-18, under 510(k) number K212371.

Who is the listed applicant for F&P Evora Full Face Mask?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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NCT07524517NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn InfantsRECRUITING

Other records listing Fisher & Paykel Healthcare, Ltd. as applicant

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Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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