AMADEO M-DR mini, AMADEO M-AX mini
K号: K182317 · 2018-09-24
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器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：IZL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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