FDA 510(k)

DW-1C

Número K: K160761 · 2016-11-22

Data da decisão2016-11-22

Código do produtoNEW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DW-1C is the device name listed in this FDA 510(k) record. The listed applicant is Dongwon Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160761. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DW-1C?

DW-1C is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Dongwon Medical Co., Ltd.. The 510(k) number is K160761.

When did DW-1C receive FDA 510(k) clearance?

DW-1C received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160761.

Who is the listed applicant for DW-1C?

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

What is the FDA product code for DW-1C?

The FDA product code for DW-1C is NEW.

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Fonte oficial

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