FDA 510(k)

IT-III主动系统

K号: K181137 · 2018-11-16

决定日期2018-11-16

产品代码DZE

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决定实质等同

器械摘要

IT-III active System is the device name listed in this FDA 510(k) record. The listed applicant is Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181137. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IT-III active System?

IT-III active System is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K181137.

When did IT-III active System receive FDA 510(k) clearance?

IT-III active System received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181137.

Who is the listed applicant for IT-III active System?

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

What is the FDA product code for IT-III active System?

The FDA product code for IT-III active System is DZE.

列明Neobiotech Co., 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。

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