FDA 510(k)

NOVA Minimally Invasive System

Número K: K182416 · 2019-06-11

Data da decisão2019-06-11

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NOVA Minimally Invasive System is the device name listed in this FDA 510(k) record. The listed applicant is Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K182416. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NOVA Minimally Invasive System?

NOVA Minimally Invasive System is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Baui Biotech Co., Ltd.. The 510(k) number is K182416.

When did NOVA Minimally Invasive System receive FDA 510(k) clearance?

NOVA Minimally Invasive System received FDA 510(k) clearance on 2019-06-11, under 510(k) number K182416.

Who is the listed applicant for NOVA Minimally Invasive System?

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

What is the FDA product code for NOVA Minimally Invasive System?

The FDA product code for NOVA Minimally Invasive System is NKB.

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Fonte oficial

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