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FDA 510(k)

MedDream

K号: K162011 · 2016-10-14

申请人Softneta Uab
决定日期2016-10-14
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

MedDream is the device name listed in this FDA 510(k) record. The listed applicant is Softneta Uab. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K162011. 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 MedDream?

MedDream is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Softneta Uab. The 510(k) number is K162011.

When did MedDream receive FDA 510(k) clearance?

MedDream received FDA 510(k) clearance on 2016-10-14, under 510(k) number K162011.

Who is the listed applicant for MedDream?

The FDA 510(k) record lists Softneta Uab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedDream?

The FDA product code for MedDream is LLZ.

相关临床试验

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列明Softneta Uab为申报人的其他记录

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相关器械(代码:LLZ)

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。

官方来源

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