Oxymag Transport And Emergency Ventilator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221634 FDA 510(k)
- FDA Product Code
- BTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5925 FDA 510(k)
- Regulation Number
- 868.5925 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Oxymag Transport And Emergency Ventilator is a powered emergency ventilator, also known as a resuscitator. It is a medical device used to provide ventilation support in emergency situations. The device is designed to be transported and used in various settings. It falls under the device class 2 and is classified under the medical specialty of anesthesiology.
The Oxymag Transport And Emergency Ventilator is supplied with a device class of 2 and a product code of BTL. It has a regulation number of 868.5925 and is registered with the FDA under the K number K221634. The device is intended for use in emergency situations and is designed to be used in a variety of settings. The manufacturer, Magnamed Tecnologia Medica S/A, has received FDA 510K authorization for the 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221634 | Class II | Active |
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Manufacturer
- Manufacturer
- Magnamed Tecnologia Medica S/A
Sources (1)
- FDA 510(k) K221634 24 fields · synced Oct 6, 2026