FDA 510(k)

Novo

N.º K: K212361 · 2022-08-11

Fecha de decisión2022-08-11

Código de productoQKQ

Comité asesorPA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Novo is the device name listed in this FDA 510(k) record. The listed applicant is PathAI, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K212361. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Novo?

Novo is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is PathAI, Inc.. The 510(k) number is K212361.

When did Novo receive FDA 510(k) clearance?

Novo received FDA 510(k) clearance on 2022-08-11, under 510(k) number K212361.

Who is the listed applicant for Novo?

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

What is the FDA product code for Novo?

The FDA product code for Novo is QKQ.

Otros registros que enlistan a PathAI, Inc. 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.

K243391AISight Dx

Dispositivos relacionados (Código: QKQ)

K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLC K243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation K250414CaloPixTribun Health

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.