FDA 510(k)

Life Essence通用瓷器系统

K号: K163251 · 2017-08-04

决定日期2017-08-04

产品代码EIH

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决定实质等同

器械摘要

Life Essence Universal Porcelain System is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K163251. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Life Essence Universal Porcelain System?

Life Essence Universal Porcelain System is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Blue Sky Bio. The 510(k) number is K163251.

When did Life Essence Universal Porcelain System receive FDA 510(k) clearance?

Life Essence Universal Porcelain System received FDA 510(k) clearance on 2017-08-04, under 510(k) number K163251.

Who is the listed applicant for Life Essence Universal Porcelain System?

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

What is the FDA product code for Life Essence Universal Porcelain System?

The FDA product code for Life Essence Universal Porcelain System is EIH.

列明Blue Sky Bio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。

K182338Blue Sky Bio 计算机正畸托槽系统

官方来源

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