FDA 510(k)

AG100s

N.º K: K221477 · 2022-12-29

Fecha de decisión2022-12-29

Código de productoBSK

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

AG100s is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221477. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AG100s?

AG100s is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K221477.

When did AG100s receive FDA 510(k) clearance?

AG100s received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221477.

Who is the listed applicant for AG100s?

The FDA 510(k) record lists Hospitech Respiration , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AG100s?

The FDA product code for AG100s is BSK.

Otros registros que enlistan a Hospitech Respiration , Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K180991AG 100s K150157AnapnoGuard 100 Sistema de Guardia Respiratoria

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.