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FDA 510(k)

Oxymag - Transport and Emergency Ventilator

K-Number: K221634 · 2023-05-24

ApplicantMagnamed Tecnologia Medica S/A
Decision Date2023-05-24
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxymag - Transport and Emergency Ventilator is a medical device manufactured by Magnamed Tecnologia Medica S/A. It received FDA 510(k) clearance on 2023-05-24 under approval number K221634. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxymag - Transport and Emergency Ventilator?

Oxymag - Transport and Emergency Ventilator is a medical device that received FDA 510(k) clearance on 2023-05-24. It is manufactured by Magnamed Tecnologia Medica S/A. The 510(k) number is K221634.

When was Oxymag - Transport and Emergency Ventilator approved by the FDA?

Oxymag - Transport and Emergency Ventilator received FDA 510(k) clearance on 2023-05-24, under approval number K221634.

What company makes Oxymag - Transport and Emergency Ventilator?

Oxymag - Transport and Emergency Ventilator is manufactured by Magnamed Tecnologia Medica S/A.

What is the FDA product code for Oxymag - Transport and Emergency Ventilator?

The FDA product code for Oxymag - Transport and Emergency Ventilator is BTL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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