FDA 510(k)

CELAUX 3

K 號：K153018 · 2016-06-23

決定日期2016-06-23

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

CELALUX 3 is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153018. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CELALUX 3?

CELALUX 3 is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Voco GmbH. The 510(k) number is K153018.

When did CELALUX 3 receive FDA 510(k) clearance?

CELALUX 3 received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153018.

Who is the listed applicant for CELALUX 3?

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

What is the FDA product code for CELALUX 3?

The FDA product code for CELALUX 3 is EBZ.

其他以 Voco GmbH 為申請人之記錄

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相關器械（代碼：EBZ）

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