FDA 510(k)

Sofjec

K-Number: K212635 · 2023-02-13

Decision Date2023-02-13

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Sofjec?

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

When was Sofjec approved by the FDA?

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

What company makes Sofjec?

Sofjec is manufactured by Hwajin Medical Co., Ltd..

What is the FDA product code for Sofjec?

The FDA product code for Sofjec is FMF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.