FDA 510(k)

AMADEO M-DR mini, AMADEO M-AX mini

K 號：K182317 · 2018-09-24

決定日期2018-09-24

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

AMADEO M-DR mini, AMADEO M-AX mini is the device name listed in this FDA 510(k) record. The listed applicant is Oehm Und Rehbein GmbH. It received FDA 510(k) clearance on 2018-09-24 under 510(k) number K182317. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AMADEO M-DR mini, AMADEO M-AX mini?

AMADEO M-DR mini, AMADEO M-AX mini is a medical device that received FDA 510(k) clearance on 2018-09-24. The listed applicant is Oehm Und Rehbein GmbH. The 510(k) number is K182317.

When did AMADEO M-DR mini, AMADEO M-AX mini receive FDA 510(k) clearance?

AMADEO M-DR mini, AMADEO M-AX mini received FDA 510(k) clearance on 2018-09-24, under 510(k) number K182317.

Who is the listed applicant for AMADEO M-DR mini, AMADEO M-AX mini?

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

What is the FDA product code for AMADEO M-DR mini, AMADEO M-AX mini?

The FDA product code for AMADEO M-DR mini, AMADEO M-AX mini is IZL.

相關器械（代碼：IZL）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IZL）

官方來源