Newport HT70 Family of Ventilators
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090888 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 HT70 Family of Ventilators is a device type classified as a ventilator, continuous, facility use. It is intended for use in anesthesiology.
The device is supplied as a reusable ventilator. It is not specified as single-use. The device is not described as MRI safe. The device is regulated under regulation number 868.5895.
Frequently asked questions
What is the Newport HT70 Family of Ventilators used for?
This device is a continuous ventilator intended for use in anesthesiology.
Is the Newport HT70 ventilator reusable or single-use?
The device is supplied as a reusable ventilator and is not specified as single-use.
Is the Newport HT70 ventilator MRI safe?
No, the device is not described as MRI safe.
What is the regulatory status of the Newport HT70 ventilator?
The device is regulated under regulation number 868.5895.
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 Medical Instruments HT70 Operating Manual, Newport™ HT70 plus ventilator - Medtronic, NEWPORT HT70 OPERATING MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090888 | Class II | Active |
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Manufacturer
- Manufacturer
- Newport Medical Instruments, Inc.
Sources (1)
- FDA 510(k) K090888 24 fields · synced Oct 6, 2026