FDA 510(k)

X-MIND Trium

K 號：K191719 · 2020-02-20

決定日期2020-02-20

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

X-MIND Trium is the device name listed in this FDA 510(k) record. The listed applicant is De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K191719. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X-MIND Trium?

X-MIND Trium is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K191719.

When did X-MIND Trium receive FDA 510(k) clearance?

X-MIND Trium received FDA 510(k) clearance on 2020-02-20, under 510(k) number K191719.

Who is the listed applicant for X-MIND Trium?

The FDA 510(k) record lists De Gotzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-MIND Trium?

The FDA product code for X-MIND Trium is MUH.

其他以 De Gotzen S.R.L. 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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