FDA 510(k)

AMADEO M-DR mini, AMADEO M-AX mini

K-Number: K182317 · 2018-09-24

Decision Date2018-09-24

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Oehm Und Rehbein GmbH. The 510(k) number is K182317.

When was AMADEO M-DR mini, AMADEO M-AX mini approved by the FDA?

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

What company makes AMADEO M-DR mini, AMADEO M-AX mini?

AMADEO M-DR mini, AMADEO M-AX mini is manufactured by Oehm Und Rehbein GmbH.

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.