FDA 510(k)

CURASYS 2 (EMDN0003)

K 號：K253199 · 2026-06-23

決定日期2026-06-23

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

CURASYS 2 (EMDN0003) is the device name listed in this FDA 510(k) record. The listed applicant is CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-06-23 under 510(k) number K253199. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CURASYS 2 (EMDN0003)?

CURASYS 2 (EMDN0003) is a medical device that received FDA 510(k) clearance on 2026-06-23. The listed applicant is CG Bio Co., Ltd.. The 510(k) number is K253199.

When did CURASYS 2 (EMDN0003) receive FDA 510(k) clearance?

CURASYS 2 (EMDN0003) received FDA 510(k) clearance on 2026-06-23, under 510(k) number K253199.

Who is the listed applicant for CURASYS 2 (EMDN0003)?

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

What is the FDA product code for CURASYS 2 (EMDN0003)?

The FDA product code for CURASYS 2 (EMDN0003) is OMP.

其他以 CG Bio Co., Ltd. 為申請人之記錄

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官方來源

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