FDA 510(k)

清晰血漿吸取器

K 號：K242857 · 2025-05-21

決定日期2025-05-21

產品代碼KGE

諮詢委員會GU

決定相當於

器材摘要

ClearHemograsper is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K242857. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearHemograsper?

ClearHemograsper is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K242857.

When did ClearHemograsper receive FDA 510(k) clearance?

ClearHemograsper received FDA 510(k) clearance on 2025-05-21, under 510(k) number K242857.

Who is the listed applicant for ClearHemograsper?

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

What is the FDA product code for ClearHemograsper?

The FDA product code for ClearHemograsper is KGE.

其他以 Finemedix Co., Ltd. 為申請人之記錄

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相關器械（代碼：KGE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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