FDA 510(k)

IS-III 活性系统_S-窄型

K号: K190849 · 2019-08-14

决定日期2019-08-14

产品代码DZE

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决定实质等同

器械摘要

IS-III active System_S-narrow Type 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 2019-08-14 under 510(k) number K190849. 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 IS-III active System_S-narrow Type?

IS-III active System_S-narrow Type is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K190849.

When did IS-III active System_S-narrow Type receive FDA 510(k) clearance?

IS-III active System_S-narrow Type received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190849.

Who is the listed applicant for IS-III active System_S-narrow Type?

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 IS-III active System_S-narrow Type?

The FDA product code for IS-III active System_S-narrow Type 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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