FDA 510(k)

Sistema de Cámara 4K 1788 con Modalidad de Imagen Avanzada; Fuente de Luz LED L12 con AIM

N.º K: K231854 · 2023-09-20

SolicitanteStryker

Fecha de decisión2023-09-20

Código de productoOWN

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K231854. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Stryker. The 510(k) number is K231854.

When did 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM receive FDA 510(k) clearance?

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM received FDA 510(k) clearance on 2023-09-20, under 510(k) number K231854.

Who is the listed applicant for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

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

What is the FDA product code for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM?

The FDA product code for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM is OWN.

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Fuente oficial

Ver en la base de datos de la FDA →

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