FDA 510(k)

Xtreme-Loop

K 號：K191053 · 2019-07-17

決定日期2019-07-17

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Xtreme-Loop is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191053. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xtreme-Loop?

Xtreme-Loop is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is Xiros, Ltd.. The 510(k) number is K191053.

When did Xtreme-Loop receive FDA 510(k) clearance?

Xtreme-Loop received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191053.

Who is the listed applicant for Xtreme-Loop?

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

What is the FDA product code for Xtreme-Loop?

The FDA product code for Xtreme-Loop is MBI.

其他以 Xiros, Ltd. 為申請人之記錄

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相關器械（代碼：MBI）

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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