FDA 510(k)

L300 Go 系统

K号: K190285 · 2019-03-14

决定日期2019-03-14

产品代码GZI

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决定实质等同

器械摘要

L300 Go System is the device name listed in this FDA 510(k) record. The listed applicant is Bioness, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K190285. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the L300 Go System?

L300 Go System is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Bioness, Inc.. The 510(k) number is K190285.

When did L300 Go System receive FDA 510(k) clearance?

L300 Go System received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190285.

Who is the listed applicant for L300 Go System?

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

What is the FDA product code for L300 Go System?

The FDA product code for L300 Go System is GZI.

列明Bioness, 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。

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官方来源

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