FDA 510(k)

troCarWash™ 系統

K 號：K233442 · 2024-05-21

決定日期2024-05-21

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

troCarWash™ System is the device name listed in this FDA 510(k) record. The listed applicant is Biotex, Inc.. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K233442. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the troCarWash™ System?

troCarWash™ System is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Biotex, Inc.. The 510(k) number is K233442.

When did troCarWash™ System receive FDA 510(k) clearance?

troCarWash™ System received FDA 510(k) clearance on 2024-05-21, under 510(k) number K233442.

Who is the listed applicant for troCarWash™ System?

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

What is the FDA product code for troCarWash™ System?

The FDA product code for troCarWash™ System is OCX.

其他以 Biotex, Inc. 為申請人之記錄

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K222695troCarWash™ 系統 K203712滑片 K161704相量钻

相關器械（代碼：OCX）

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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