FDA 510(k)

SMARTmatic

K 號：K163239 · 2017-03-17

決定日期2017-03-17

產品代碼EFA

諮詢委員會DE

決定相當於

器材摘要

SMARTmatic is the device name listed in this FDA 510(k) record. The listed applicant is Kaltenbach & Voigt GmbH. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K163239. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SMARTmatic?

SMARTmatic is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Kaltenbach & Voigt GmbH. The 510(k) number is K163239.

When did SMARTmatic receive FDA 510(k) clearance?

SMARTmatic received FDA 510(k) clearance on 2017-03-17, under 510(k) number K163239.

Who is the listed applicant for SMARTmatic?

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

What is the FDA product code for SMARTmatic?

The FDA product code for SMARTmatic is EFA.

其他以 Kaltenbach & Voigt GmbH 為申請人之記錄

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官方來源

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