FDA 510(k)

複合W疣去除系統雙功率

K 號：K161294 · 2016-09-15

決定日期2016-09-15

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

Compound W Wart Removal System Dual Power is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Products, Inc.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K161294. 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 Compound W Wart Removal System Dual Power?

Compound W Wart Removal System Dual Power is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Medtech Products, Inc.. The 510(k) number is K161294.

When did Compound W Wart Removal System Dual Power receive FDA 510(k) clearance?

Compound W Wart Removal System Dual Power received FDA 510(k) clearance on 2016-09-15, under 510(k) number K161294.

Who is the listed applicant for Compound W Wart Removal System Dual Power?

The FDA 510(k) record lists Medtech Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compound W Wart Removal System Dual Power?

The FDA product code for Compound W Wart Removal System Dual Power is GEH.

其他以 Medtech Products, Inc. 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。

K242803複合W皮膚疣去除器 K202974DenTek 新鮮保護牙護器 K180933DenTek 絕佳牙科保護器 K172373複合W氮氫冷凍劑 K163401Nix超級跳蚤治療組合

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

在 FDA 資料庫中查看 →

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。