FDA 510(k)

IB Lab LAMA

N.º K: K223646 · 2023-06-16

Fecha de decisión2023-06-16

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

IB Lab LAMA is the device name listed in this FDA 510(k) record. The listed applicant is Ib Lab GmbH. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K223646. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IB Lab LAMA?

IB Lab LAMA is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Ib Lab GmbH. The 510(k) number is K223646.

When did IB Lab LAMA receive FDA 510(k) clearance?

IB Lab LAMA received FDA 510(k) clearance on 2023-06-16, under 510(k) number K223646.

Who is the listed applicant for IB Lab LAMA?

The FDA 510(k) record lists Ib Lab GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IB Lab LAMA?

The FDA product code for IB Lab LAMA is QIH.

Otros registros que enlistan a Ib Lab GmbH 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.

K192109KOALA

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Fuente oficial

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