FDA 510(k)

KJ 微型植入系统

K号: K151970 · 2016-10-21

决定日期2016-10-21

产品代码DZE

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决定实质等同

器械摘要

KJ Mini Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Kj Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K151970. 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 KJ Mini Implant System?

KJ Mini Implant System is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Kj Meditech Co., Ltd.. The 510(k) number is K151970.

When did KJ Mini Implant System receive FDA 510(k) clearance?

KJ Mini Implant System received FDA 510(k) clearance on 2016-10-21, under 510(k) number K151970.

Who is the listed applicant for KJ Mini Implant System?

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

What is the FDA product code for KJ Mini Implant System?

The FDA product code for KJ Mini Implant System is DZE.

列明Kj Meditech 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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