FDA 510(k)

VITA Ambria

K 號：K193436 · 2020-05-14

決定日期2020-05-14

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

VITA Ambria is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zahnfabrik GmbH H Rauter & CO. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K193436. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITA Ambria?

VITA Ambria is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Vita Zahnfabrik GmbH H Rauter & CO. The 510(k) number is K193436.

When did VITA Ambria receive FDA 510(k) clearance?

VITA Ambria received FDA 510(k) clearance on 2020-05-14, under 510(k) number K193436.

Who is the listed applicant for VITA Ambria?

The FDA 510(k) record lists Vita Zahnfabrik GmbH H Rauter & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA Ambria?

The FDA product code for VITA Ambria is EIH.

其他以 Vita Zahnfabrik GmbH H Rauter & CO 為申請人之記錄

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K211854VITA Akzent LC K193434VITA LUMEX AC

相關器械（代碼：EIH）

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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官方來源

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