FDA 510(k)

凍點與私人標籤版本

K 號：K242625 · 2024-10-25

決定日期2024-10-25

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

Freeze Point & Private Label Versions is the device name listed in this FDA 510(k) record. The listed applicant is Cryoconcepts LP. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242625. 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 Freeze Point & Private Label Versions?

Freeze Point & Private Label Versions is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Cryoconcepts LP. The 510(k) number is K242625.

When did Freeze Point & Private Label Versions receive FDA 510(k) clearance?

Freeze Point & Private Label Versions received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242625.

Who is the listed applicant for Freeze Point & Private Label Versions?

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 Freeze Point & Private Label Versions?

The FDA product code for Freeze Point & Private Label Versions is GEH.

其他以 Cryoconcepts LP 為申請人之記錄

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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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。

K262420Maverix 冷凍切片儀 Pro (MCB Pro) (MCBP-1000)；Maverix 冷凍針筒 (CC-1000)Serpex Medical K261068Maverix冷凍切片探針（MCB1000）；Maverix冷凍針筒（CC1000）Serpex Medical K261806ERBECRYO 2 冷凍外科儀器及附件Erbe Elektromedizin GmbH K253230ERBECRYO 2 冷凍外科儀器及附件：ERBECRYO 2 冷凍外科儀器；Erbe 柔性冷凍針Erbe Elektromedizin GmbH K252198Advanced 冷冻皮肤疣去除器（Advanced 皮肤疣去除器）Medical Brands Laboratories B.V.K260377XSense冷凍消融系統搭配冷凍探針IceCure Medical , Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。