Modification to Galileo Gold Ventilator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080181 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 Modification to Galileo Gold is a continuous, facility-use ventilator designed to deliver positive pressure ventilatory support. As classified under FDA code 3010017366, it falls within the category of Class II medical devices, intended for adult, pediatric, infant, and neonatal patients in controlled healthcare settings. The device is engineered to provide mechanical ventilation in critical care environments, including patient bedside and intrafacility transport scenarios.
This ventilator modification is supplied for facility-based use and is regulated under FDA 510(k) clearance (K080181), with a decision date of June 24, 2008. It is intended for use in hospital and institutional environments where healthcare professionals administer patient care. The device adheres to regulatory standards outlined in 21 CFR 868.5895 and is not indicated for home or ambulatory use. No specific sterility or single-use/reusable designation is provided in the data.
Frequently asked questions
What is the Galileo Gold Ventilator Modification designed for?
The Galileo Gold Ventilator Modification is a continuous, facility-use ventilator intended to deliver positive pressure ventilatory support. It is specifically engineered for use in controlled healthcare environments, including patient bedside and intrafacility transport scenarios. This device is designed to provide mechanical ventilation in critical care settings for adult, pediatric, infant, and neonatal patients.
Where is this ventilator modification intended for use?
This modification is exclusively intended for facility-based use in hospital and institutional environments where healthcare professionals administer patient care. It is not approved for home or ambulatory use. The device adheres to regulatory standards outlined in 21 CFR 868.5895, ensuring its suitability for controlled healthcare settings.
Is the Galileo Gold Ventilator Modification single-use or reusable?
The provided data does not specify whether the Galileo Gold Ventilator Modification is single-use or reusable. However, as it is a facility-use device, it is likely designed for reuse within a healthcare setting, following proper cleaning, disinfection, and maintenance protocols as outlined by the manufacturer.
What regulatory approval does this ventilator modification hold?
The Galileo Gold Ventilator Modification holds FDA 510(k) clearance under the reference number K080181, with a decision date of June 24, 2008. It is classified as a Class II medical device under FDA code 3010017366 and is determined to be substantially equivalent to a predicate device. This clearance ensures it meets regulatory standards for use in healthcare facilities.
How is the Galileo Gold Ventilator Modification supplied?
The device is supplied for facility-based use, meaning it is intended to be utilized within hospitals or institutional settings. It is not designed for individual patient home use or ambulatory care. The modification is part of the broader Galileo Gold ventilator system, which is regulated under specific FDA guidelines to ensure its safe and effective use in critical care environments.
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: K080181 - MODIFICATION TO GALILEO GOLD | FDA 510 (k), PDF K080181 - Modification to Galileo Gold, MODIFICATION TO GALILEO GOLD (K080181) — FDA 510(k) | Innolitics, PDF K080181 - Modification to Galileo Gold
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080181 | Class II | Active |
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Manufacturer
- Manufacturer
- Hamilton Medical AG
Sources (1)
- FDA 510(k) K080181 24 fields · synced Oct 1, 2026