FDA 510(k)

4K UHD Camera System

Número K: K200216 · 2020-08-21

RequerenteScivita Medical Technology Co., Ltd.

Data da decisão2020-08-21

Código do produtoHET

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

4K UHD Camera System is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-21 under 510(k) number K200216. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 4K UHD Camera System?

4K UHD Camera System is a medical device that received FDA 510(k) clearance on 2020-08-21. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K200216.

When did 4K UHD Camera System receive FDA 510(k) clearance?

4K UHD Camera System received FDA 510(k) clearance on 2020-08-21, under 510(k) number K200216.

Who is the listed applicant for 4K UHD Camera System?

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

What is the FDA product code for 4K UHD Camera System?

The FDA product code for 4K UHD Camera System is HET.

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