FDA 510(k)

Oxymag - Transport and Emergency Ventilator

N.º K: K221634 · 2023-05-24

SolicitanteMagnamed Tecnologia Medica S/A

Fecha de decisión2023-05-24

Código de productoBTL

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Magnamed Tecnologia Medica S/A. The 510(k) number is K221634.

When did Oxymag - Transport and Emergency Ventilator receive FDA 510(k) clearance?

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

Who is the listed applicant for Oxymag - Transport and Emergency Ventilator?

The FDA 510(k) record lists Magnamed Tecnologia Medica S/A as the applicant. This does not by itself establish the device manufacturer.

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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Fuente oficial

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