FDA 510(k)

Broncoflex Agile, Broncoflex Vortex, Screeni

N.º K: K212886 · 2022-02-16

Fecha de decisión2022-02-16

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Broncoflex Agile, Broncoflex Vortex, Screeni is the device name listed in this FDA 510(k) record. The listed applicant is Axess Vision Technology. It received FDA 510(k) clearance on 2022-02-16 under 510(k) number K212886. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Broncoflex Agile, Broncoflex Vortex, Screeni?

Broncoflex Agile, Broncoflex Vortex, Screeni is a medical device that received FDA 510(k) clearance on 2022-02-16. The listed applicant is Axess Vision Technology. The 510(k) number is K212886.

When did Broncoflex Agile, Broncoflex Vortex, Screeni receive FDA 510(k) clearance?

Broncoflex Agile, Broncoflex Vortex, Screeni received FDA 510(k) clearance on 2022-02-16, under 510(k) number K212886.

Who is the listed applicant for Broncoflex Agile, Broncoflex Vortex, Screeni?

The FDA 510(k) record lists Axess Vision Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Broncoflex Agile, Broncoflex Vortex, Screeni?

The FDA product code for Broncoflex Agile, Broncoflex Vortex, Screeni is EOQ.

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Otros registros que enlistan a Axess Vision Technology como solicitante

K202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

Dispositivos relacionados (Código: EOQ)

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Fuente oficial

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