FDA 510(k)

Corrugated tube with mouthpiece accessory

N.º K: K203400 · 2021-06-14

SolicitanteTrudell Medical International

Fecha de decisión2021-06-14

Código de productoCAF

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Corrugated tube with mouthpiece accessory is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2021-06-14 under 510(k) number K203400. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Corrugated tube with mouthpiece accessory?

Corrugated tube with mouthpiece accessory is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Trudell Medical International. The 510(k) number is K203400.

When did Corrugated tube with mouthpiece accessory receive FDA 510(k) clearance?

Corrugated tube with mouthpiece accessory received FDA 510(k) clearance on 2021-06-14, under 510(k) number K203400.

Who is the listed applicant for Corrugated tube with mouthpiece accessory?

The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Corrugated tube with mouthpiece accessory?

The FDA product code for Corrugated tube with mouthpiece accessory is CAF.

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Fuente oficial

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