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Nasal/Oral Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K925587

by Respironics, Inc.

Identifiers

510(k) Number
K925587 FDA 510(k)
FDA Product Code
BZD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5905 FDA 510(k)
Regulation Number
868.5905 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A Nasal/Oral Mask is a device intended to deliver airflow to the patient via the nose and/or mouth. It is classified as a ventilator, non-continuous (respirator) under FDA device classification.

This mask is supplied non-sterile and is intended for reusable use. It is used in adult patients within the anesthesiology medical specialty. The device received FDA 510(k) clearance under K925587 on September 14, 1993, and is regulated under 21 CFR 868.5905.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CPAP masks | Philips | Sleep and Respiratory Care, Amazon.com: Respironics Cpap Masks, Respironics CPAP Mask Nasal / Oral Style - M-463195-4042 - Pack of 5, Amazon.com: Respironics Nasal Mask, AF531 Oro-Nasal Mask - Hospital Respiratory Mask - Philips

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA 510(k) K925587 24 fields · synced Sep 25, 2026