FDA 510(k)

Servo-air 4.0 Ventilator System

N.º K: K192604 · 2020-06-18

Fecha de decisión2020-06-18

Código de productoCBK

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Servo-air 4.0 Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critica Care AB. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K192604. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Servo-air 4.0 Ventilator System?

Servo-air 4.0 Ventilator System is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Maquet Critica Care AB. The 510(k) number is K192604.

When did Servo-air 4.0 Ventilator System receive FDA 510(k) clearance?

Servo-air 4.0 Ventilator System received FDA 510(k) clearance on 2020-06-18, under 510(k) number K192604.

Who is the listed applicant for Servo-air 4.0 Ventilator System?

The FDA 510(k) record lists Maquet Critica Care AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Servo-air 4.0 Ventilator System?

The FDA product code for Servo-air 4.0 Ventilator System is CBK.

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Fuente oficial

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