FDA 510(k)

TempoCem 清晰

K 號：K160443 · 2016-09-30

決定日期2016-09-30

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

TempoCem Clear is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K160443. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TempoCem Clear?

TempoCem Clear is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Dmg USA, Inc.. The 510(k) number is K160443.

When did TempoCem Clear receive FDA 510(k) clearance?

TempoCem Clear received FDA 510(k) clearance on 2016-09-30, under 510(k) number K160443.

Who is the listed applicant for TempoCem Clear?

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

What is the FDA product code for TempoCem Clear?

The FDA product code for TempoCem Clear is EMA.

其他以 Dmg USA, Inc. 為申請人之記錄

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相關器械（代碼：EMA）

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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