FDA 510(k)

Portux CAD/CAM 光盘

K号: K192153 · 2019-11-07

决定日期2019-11-07

产品代码EBG

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决定实质等同

器械摘要

Portux CAD/CAM Disc is the device name listed in this FDA 510(k) record. The listed applicant is New Stetic, SA. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192153. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Portux CAD/CAM Disc?

Portux CAD/CAM Disc is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is New Stetic, SA. The 510(k) number is K192153.

When did Portux CAD/CAM Disc receive FDA 510(k) clearance?

Portux CAD/CAM Disc received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192153.

Who is the listed applicant for Portux CAD/CAM Disc?

The FDA 510(k) record lists New Stetic, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portux CAD/CAM Disc?

The FDA product code for Portux CAD/CAM Disc is EBG.

列明New Stetic, SA为申报人的其他记录

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