FDA 510(k)

GT300；GT300-C

K 號：K250060 · 2025-10-08

決定日期2025-10-08

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

GT300; GT300-C is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K250060. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GT300; GT300-C?

GT300; GT300-C is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K250060.

When did GT300; GT300-C receive FDA 510(k) clearance?

GT300; GT300-C received FDA 510(k) clearance on 2025-10-08, under 510(k) number K250060.

Who is the listed applicant for GT300; GT300-C?

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

What is the FDA product code for GT300; GT300-C?

The FDA product code for GT300; GT300-C is OAS.

其他以 Genoray Co., Ltd. 為申請人之記錄

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