FDA 510(k)

AR_N 类型植入系统

K号: K171297 · 2018-01-31

决定日期2018-01-31

产品代码DZE

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决定实质等同

器械摘要

AR_N Type Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biotem Co., Ltd.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K171297. 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 AR_N Type Implant System?

AR_N Type Implant System is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Biotem Co., Ltd.. The 510(k) number is K171297.

When did AR_N Type Implant System receive FDA 510(k) clearance?

AR_N Type Implant System received FDA 510(k) clearance on 2018-01-31, under 510(k) number K171297.

Who is the listed applicant for AR_N Type Implant System?

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

What is the FDA product code for AR_N Type Implant System?

The FDA product code for AR_N Type Implant System is DZE.

列明Biotem 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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官方来源

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