FDA 510(k)

TR90BH

K 號：K182207 · 2018-12-14

決定日期2018-12-14

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

TR90BH is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182207. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TR90BH?

TR90BH is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Minxray, Inc.. The 510(k) number is K182207.

When did TR90BH receive FDA 510(k) clearance?

TR90BH received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182207.

Who is the listed applicant for TR90BH?

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

What is the FDA product code for TR90BH?

The FDA product code for TR90BH is IZL.

其他以 Minxray, Inc. 為申請人之記錄

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相關器械（代碼：IZL）

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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