FDA 510(k)

Sofjec

Numéro K : K212635 · 2023-02-13

Date de décision2023-02-13

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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