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Veolar Ventilator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K881482

by Hamilton Medical, Inc.

Identifiers

510(k) Number
K881482 FDA 510(k)
FDA Product Code
CBK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5895 FDA 510(k)
Regulation Number
868.5895 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Veolar Ventilator is a continuous ventilator device for facility use. It is designed to provide mechanical ventilation support to patients in a clinical setting.

The Veolar Ventilator is manufactured by Hamilton Medical, Inc. and is a Class II device with FDA 510(k) clearance (K881482). It is intended for facility use and is regulated under product code CBK.

Frequently asked questions

What is the Veolar Ventilator used for?

The Veolar Ventilator is a continuous ventilator device designed to provide mechanical ventilation support to patients in clinical settings. It is intended for facility use and is manufactured by Hamilton Medical, Inc.

What is the regulatory status of the Veolar Ventilator?

The Veolar Ventilator is a Class II device with FDA 510(k) clearance (K881482). It is regulated under product code CBK and was determined to be substantially equivalent to predicate devices.

Is the Veolar Ventilator reusable or single-use?

The device data does not specify whether the Veolar Ventilator is designed for single-use or multiple uses. For information on reuse or sterilization procedures, please consult the manufacturer's instructions for use.

What sizes or models of the Veolar Ventilator are available?

The device data does not provide information about different sizes or models of the Veolar Ventilator. For specific product variations, please contact Hamilton Medical, Inc. directly or refer to their product catalog.

How should the Veolar Ventilator be stored?

The device data does not include specific storage instructions for the Veolar Ventilator. Proper storage conditions would be detailed in the manufacturer's instructions for use, which should be followed to maintain device integrity and functionality.

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.

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) K881482 24 fields · synced Sep 23, 2026