FDA 510(k)

Neocis规划软件应用（NPSA）用于第三方PC

K号: K191363 · 2019-10-02

决定日期2019-10-02

产品代码PLV

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决定实质等同

器械摘要

Neocis Planning Software Application (NPSA) for 3rd Party PCs is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191363. 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 Planning Software Application (NPSA) for 3rd Party PCs?

Neocis Planning Software Application (NPSA) for 3rd Party PCs is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Neocis, Inc.. The 510(k) number is K191363.

When did Neocis Planning Software Application (NPSA) for 3rd Party PCs receive FDA 510(k) clearance?

Neocis Planning Software Application (NPSA) for 3rd Party PCs received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191363.

Who is the listed applicant for Neocis Planning Software Application (NPSA) for 3rd Party PCs?

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 Planning Software Application (NPSA) for 3rd Party PCs?

The FDA product code for Neocis Planning Software Application (NPSA) for 3rd Party PCs is PLV.

列明Neocis, Inc.为申报人的其他记录

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