Identifiers
- 510(k) Number
- K121891 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 Newport Aura Ventilator is a continuous ventilator for facility use, intended for use by qualified, trained personnel under the direction of a physician. It is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The device is supplied as a Class II medical device with FDA 510(k) clearance K121891, granted on 2012-11-09, under regulation 868.5895. It is manufactured by Newport Medical Instruments, Inc. and is intended for single-patient use in various healthcare settings.
Frequently asked questions
What is the Newport Aura Ventilator intended for?
The Newport Aura Ventilator is a continuous ventilator for facility use, intended for use by qualified, trained personnel under the direction of a physician. It is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
How is the Newport Aura Ventilator supplied and what is its sterility status?
The device is supplied as a Class II medical device with FDA 510(k) clearance K121891, granted on 2012-11-09. It is manufactured by Newport Medical Instruments, Inc. and is intended for single-patient use in various healthcare settings.
What regulatory approvals does the Newport Aura Ventilator have?
The Newport Aura Ventilator has FDA 510(k) clearance K121891, granted on 2012-11-09, under regulation 868.5895. It is classified as a Class II medical device and is manufactured by Newport Medical Instruments, Inc.
In what healthcare environments can the Newport Aura Ventilator be used?
The Newport Aura Ventilator can be used in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications. It is designed for facility use by qualified, trained personnel under physician direction.
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: NEWPORT AURA VENTILATOR (K121891) — FDA 510(k) | Innolitics, NEWPORT AURA VENTILATOR 510 (k) K121891 - FDA.report, Newport Aura Ventilator - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121891 | Class II | Active |
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Manufacturer
- Manufacturer
- Newport Medical Instruments, Inc.
Sources (1)
- FDA 510(k) K121891 24 fields · synced Oct 6, 2026