FDA 510(k)

LIGHTSonic BUBM

K号: K170761 · 2018-04-13

决定日期2018-04-13

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

LIGHTSonic BUBM is the device name listed in this FDA 510(k) record. The listed applicant is Lightmed USA, Inc.. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K170761. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIGHTSonic BUBM?

LIGHTSonic BUBM is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Lightmed USA, Inc.. The 510(k) number is K170761.

When did LIGHTSonic BUBM receive FDA 510(k) clearance?

LIGHTSonic BUBM received FDA 510(k) clearance on 2018-04-13, under 510(k) number K170761.

Who is the listed applicant for LIGHTSonic BUBM?

The FDA 510(k) record lists Lightmed USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGHTSonic BUBM?

The FDA product code for LIGHTSonic BUBM is IYO.

列明Lightmed USA, Inc.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。

K183173LIGHTMED超声系统

官方来源

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