FDA 510(k)

Neck Care Therapy, Model: SYK 509B

Número K: K172897 · 2018-12-07

RequerenteShenzhen Osto Technology Co., Ltd.

Data da decisão2018-12-07

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Neck Care Therapy, Model: SYK 509B is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K172897. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Neck Care Therapy, Model: SYK 509B?

Neck Care Therapy, Model: SYK 509B is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172897.

When did Neck Care Therapy, Model: SYK 509B receive FDA 510(k) clearance?

Neck Care Therapy, Model: SYK 509B received FDA 510(k) clearance on 2018-12-07, under 510(k) number K172897.

Who is the listed applicant for Neck Care Therapy, Model: SYK 509B?

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

What is the FDA product code for Neck Care Therapy, Model: SYK 509B?

The FDA product code for Neck Care Therapy, Model: SYK 509B is NUH.

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Outros registros que listam Shenzhen Osto Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: NUH)

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