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Aladdin Monitoring Oxygen/Air Mixer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960359

by Hamilton Medical, Inc.

Identifiers

510(k) Number
K960359 FDA 510(k)
FDA Product Code
BZR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5330 FDA 510(k)
Regulation Number
868.5330 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient. The Aladdin Monitoring Oxygen/Air Mixer is designed to mix oxygen and air gases and provide the mixed gas at a prescribed oxygen concentration level via a flowmeter with a range of 1 to 10 LPM.

The device is intended for use within the hospital or institution. It is supplied as a reusable device and has received FDA 510(k) clearance under K960359, classified as a Class II device with product code BZR under regulation number 868.5330.

Frequently asked questions

What is the Aladdin Monitoring Oxygen/Air Mixer used for?

The Aladdin Monitoring Oxygen/Air Mixer is intended for use with a respiratory support apparatus to control the mixing of oxygen and air gases that are to be breathed by a patient, providing the mixed gas at a prescribed oxygen concentration level.

How is the Aladdin Monitoring Oxygen/Air Mixer supplied and is it reusable?

The device is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and disinfection between patients, as indicated in its FDA 510(k) submission.

What is the flow range of the Aladdin Monitoring Oxygen/Air Mixer?

The Aladdin Monitoring Oxygen/Air Mixer provides mixed gas via a flowmeter with a range of 1 to 10 liters per minute (LPM), allowing precise control of gas delivery for respiratory support.

What regulatory pathway was used for the Aladdin Monitoring Oxygen/Air Mixer?

The Aladdin Monitoring Oxygen/Air Mixer received FDA 510(k) clearance under submission number K960359, demonstrating substantial equivalence to a legally marketed predicate device.

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: ALADDIN MONITORING OXYGEN/AIR MIXER by HAMILTON MEDICAL, INC. | FDA 510 ..., ALADDIN II MONITORING OXYGEN/AIR MONITOR by HAMILTON MEDICAL, INC ..., K990293 FDA 510(k) - ALADDIN II MONITORING OXYGEN/AIR MONITOR, ALADDIN II MONITORING OXYGEN/AIR MONITOR (K990293) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hamilton Medical, Inc.

Sources (1)

  • FDA 510(k) K960359 24 fields · synced Oct 6, 2026