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F&P Evora Nasal Mask Nasal A Model - Wide)

by Fisher & Paykel Healthcare, Inc.

510(k) K200089

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200089 Date2 Jun 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZD
Models / Variants
Wide)
F
F
Wide)
F
FDA applicant
Fisher & Paykel Healthcare, Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The F&P Evora Nasal Mask is a nasal mask designed to deliver PAP therapy in the treatment of obstructive sleep apnea. It features CapFit headgear and Dynamic Support Technology. The mask is available in various sizes, including Small, Medium, Large, and Wide.

The F&P Evora Nasal Mask is supplied in different configurations, including a Nasal A Model and a Nasal Fit Pack with Small, Medium, and Large sizes. It is a single-use device and is intended for use in a home or sleep lab setting. The device has been cleared by the FDA and is classified under regulation number 868.5905.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the F&P Evora Nasal Mask used for?

    The F&P Evora Nasal Mask is used to deliver PAP therapy in the treatment of obstructive sleep apnea.

  • Is the F&P Evora Nasal Mask a single-use device?

    Yes, the F&P Evora Nasal Mask is intended for single-use and is available in different configurations, including a Nasal A Model and a Nasal Fit Pack.

  • What sizes is the F&P Evora Nasal Mask available in?

    The F&P Evora Nasal Mask is available in various sizes, including Small, Medium, Large, and Wide.

  • Where can the F&P Evora Nasal Mask be used?

    The F&P Evora Nasal Mask is intended for use in a home or sleep lab setting.