FDA 510(k)

Ortho System

K号: K171634 · 2018-01-17

决定日期2018-01-17

产品代码PNN

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决定实质等同

器械摘要

Ortho System is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape A/S. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K171634. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ortho System?

Ortho System is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is 3Shape A/S. The 510(k) number is K171634.

When did Ortho System receive FDA 510(k) clearance?

Ortho System received FDA 510(k) clearance on 2018-01-17, under 510(k) number K171634.

Who is the listed applicant for Ortho System?

The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ortho System?

The FDA product code for Ortho System is PNN.

列明3Shape A/S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。

K200100牙槽设计 K1919113Shape Splint Design K180941Ortho System K163677Ortho System K161884Ortho System K1514553Shape Abutment Designer Software

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官方来源

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