FDA 510(k)

Simplicit90Y

K号: K182016 · 2018-12-06

决定日期2018-12-06

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Simplicit90Y is the device name listed in this FDA 510(k) record. The listed applicant is Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K182016. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Simplicit90Y?

Simplicit90Y is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K182016.

When did Simplicit90Y receive FDA 510(k) clearance?

Simplicit90Y received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182016.

Who is the listed applicant for Simplicit90Y?

The FDA 510(k) record lists Mirada Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplicit90Y?

The FDA product code for Simplicit90Y is LLZ.

列明Mirada Medical, Ltd.为申报人的其他记录

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。

K220779XD设备名称医疗设备监管文本翻译如下： XD设备名称医疗设备监管文本请注意，以下翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。请注意，以下翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。 [保留原文]K202297Aline消融智能系统 K181572工作流程盒

官方来源

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