FDA 510(k)

TelioCAD 多功能醫療設備

K 號：K153753 · 2016-04-12

決定日期2016-04-12

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

TelioCAD Multi is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2016-04-12 under 510(k) number K153753. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TelioCAD Multi?

TelioCAD Multi is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K153753.

When did TelioCAD Multi receive FDA 510(k) clearance?

TelioCAD Multi received FDA 510(k) clearance on 2016-04-12, under 510(k) number K153753.

Who is the listed applicant for TelioCAD Multi?

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

What is the FDA product code for TelioCAD Multi?

The FDA product code for TelioCAD Multi is EBG.

其他以 Ivoclar Vivadent, Inc. 為申請人之記錄

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相關器械（代碼：EBG）

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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