FDA 510(k)

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)

N.º K: K230216 · 2023-02-23

SolicitanteStryker

Fecha de decisión2023-02-23

Código de productoGCJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K230216. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Stryker. The 510(k) number is K230216.

When did 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) receive FDA 510(k) clearance?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230216.

Who is the listed applicant for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

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 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

The FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is GCJ.

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