FDA 510(k)

醫療設備名稱：Histofreezer V

K 號：K240106 · 2024-06-10

決定日期2024-06-10

產品代碼GEH

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

Histofreezer V is the device name listed in this FDA 510(k) record. The listed applicant is Cryoconcepts LP. It received FDA 510(k) clearance on 2024-06-10 under 510(k) number K240106. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Histofreezer V?

Histofreezer V is a medical device that received FDA 510(k) clearance on 2024-06-10. The listed applicant is Cryoconcepts LP. The 510(k) number is K240106.

When did Histofreezer V receive FDA 510(k) clearance?

Histofreezer V received FDA 510(k) clearance on 2024-06-10, under 510(k) number K240106.

Who is the listed applicant for Histofreezer V?

The FDA 510(k) record lists Cryoconcepts LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Histofreezer V?

The FDA product code for Histofreezer V is GEH.

其他以 Cryoconcepts LP 為申請人之記錄

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相關器械（代碼：GEH）

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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