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Single Use Nebulizer-Adjust-Air Entrain

FDA 510(k)

Class II (US FDA 510(k))

510(k) K834077

by Airlife, Inc.

Identifiers

510(k) Number
K834077 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Single Use Nebulizer-Adjust-Air Entrain is a medical device designed for the delivery of aerosolized medication or humidity to a patient. It features an adjustable air entrainment mechanism to control the concentration of oxygen or the density of the aerosol output.

This device is intended for single use and is supplied by Airlife, Inc. It has received FDA 510(k) clearance under the product code CAF. Users should follow standard clinical protocols for the setup and operation of nebulization equipment in an anesthesiology or respiratory care setting.

Frequently asked questions

What is the primary function of the Single Use Nebulizer-Adjust-Air Entrain?

This device is designed to deliver aerosolized medication or humidity to patients. It includes an adjustable air entrainment mechanism that allows clinicians to control the density of the aerosol output or the concentration of oxygen provided during respiratory care.

Is this device intended for reuse?

No, this device is intended for single use only. It should be disposed of after a single patient application to maintain hygiene standards and prevent cross-contamination in respiratory or anesthesiology settings.

What is the regulatory status of this nebulizer?

The Single Use Nebulizer-Adjust-Air Entrain has received FDA 510(k) clearance under the product code CAF. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

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: SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN (K834077) — FDA 510 (k ..., SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN (K834077) — FDA 510 (k ..., 510(k) K834077 — SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN, Airlife, Inc. - 76 FDA 510 (k) Anesthesiology Devices (Since 1979), Airlife, Inc. · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Airlife, Inc.

Sources (1)

  • FDA 510(k) K834077 24 fields · synced Sep 26, 2026