FDA 510(k)

Neocis引导系统（NGS）带口腔内标记阵列

K号: K211129 · 2021-07-28

决定日期2021-07-28

产品代码PLV

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决定实质等同

器械摘要

Neocis Guidance System (NGS) with Intraoral Fiducial Array is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211129. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neocis Guidance System (NGS) with Intraoral Fiducial Array?

Neocis Guidance System (NGS) with Intraoral Fiducial Array is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Neocis, Inc.. The 510(k) number is K211129.

When did Neocis Guidance System (NGS) with Intraoral Fiducial Array receive FDA 510(k) clearance?

Neocis Guidance System (NGS) with Intraoral Fiducial Array received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211129.

Who is the listed applicant for Neocis Guidance System (NGS) with Intraoral Fiducial Array?

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

What is the FDA product code for Neocis Guidance System (NGS) with Intraoral Fiducial Array?

The FDA product code for Neocis Guidance System (NGS) with Intraoral Fiducial Array is PLV.

列明Neocis, Inc.为申报人的其他记录

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