FDA 510(k)

Sofjec

Номер K: K212635 · 2023-02-13

Дата решения2023-02-13

Код продуктаFMF

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Sofjec is the device name listed in this FDA 510(k) record. The listed applicant is Hwajin Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K212635. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sofjec?

Sofjec is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Hwajin Medical Co., Ltd.. The 510(k) number is K212635.

When did Sofjec receive FDA 510(k) clearance?

Sofjec received FDA 510(k) clearance on 2023-02-13, under 510(k) number K212635.

Who is the listed applicant for Sofjec?

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

What is the FDA product code for Sofjec?

The FDA product code for Sofjec is FMF.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FMF)

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Официальный источник

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