FDA 510(k)

Vlab

N.º K: K230148 · 2023-10-11

Fecha de decisión2023-10-11

Código de productoGWL

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vlab is the device name listed in this FDA 510(k) record. The listed applicant is Dormotech Medical, Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K230148. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vlab?

Vlab is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Dormotech Medical, Ltd.. The 510(k) number is K230148.

When did Vlab receive FDA 510(k) clearance?

Vlab received FDA 510(k) clearance on 2023-10-11, under 510(k) number K230148.

Who is the listed applicant for Vlab?

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

What is the FDA product code for Vlab?

The FDA product code for Vlab is GWL.

Otros registros que enlistan a Dormotech Medical, 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.

K242290DormoTech NLab

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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.