FDA 510(k)

比奧威PICC針鞘S套件

K 號：K192246 · 2020-04-30

決定日期2020-04-30

產品代碼LJS

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

Biowy PICC Catheter S Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biowy Corporation. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K192246. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biowy PICC Catheter S Kit?

Biowy PICC Catheter S Kit is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Biowy Corporation. The 510(k) number is K192246.

When did Biowy PICC Catheter S Kit receive FDA 510(k) clearance?

Biowy PICC Catheter S Kit received FDA 510(k) clearance on 2020-04-30, under 510(k) number K192246.

Who is the listed applicant for Biowy PICC Catheter S Kit?

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

What is the FDA product code for Biowy PICC Catheter S Kit?

The FDA product code for Biowy PICC Catheter S Kit is LJS.

其他以 Biowy Corporation 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。

K233658比奧威 Tym 管道 (TT)K173956比奧威PlCC心导管

相關器械（代碼：LJS）

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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