FDA 510(k)

超心導管 5 (26G)

K 號：K172496 · 2018-03-23

決定日期2018-03-23

產品代碼FOZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

SUPERCATH 5 (26G) is the device name listed in this FDA 510(k) record. The listed applicant is Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K172496. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SUPERCATH 5 (26G)?

SUPERCATH 5 (26G) is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K172496.

When did SUPERCATH 5 (26G) receive FDA 510(k) clearance?

SUPERCATH 5 (26G) received FDA 510(k) clearance on 2018-03-23, under 510(k) number K172496.

Who is the listed applicant for SUPERCATH 5 (26G)?

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

What is the FDA product code for SUPERCATH 5 (26G)?

The FDA product code for SUPERCATH 5 (26G) is FOZ.

其他以 Togo Medikit Co., Ltd. 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：FOZ）

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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