FDA 510(k)

精英SPK，指南針，精英SPK套件

K 號：K160500 · 2016-04-20

決定日期2016-04-20

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Elite SPK, Compasso, Elite SPK Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ncs Lab Srl. It received FDA 510(k) clearance on 2016-04-20 under 510(k) number K160500. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elite SPK, Compasso, Elite SPK Kit?

Elite SPK, Compasso, Elite SPK Kit is a medical device that received FDA 510(k) clearance on 2016-04-20. The listed applicant is Ncs Lab Srl. The 510(k) number is K160500.

When did Elite SPK, Compasso, Elite SPK Kit receive FDA 510(k) clearance?

Elite SPK, Compasso, Elite SPK Kit received FDA 510(k) clearance on 2016-04-20, under 510(k) number K160500.

Who is the listed applicant for Elite SPK, Compasso, Elite SPK Kit?

The FDA 510(k) record lists Ncs Lab Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elite SPK, Compasso, Elite SPK Kit?

The FDA product code for Elite SPK, Compasso, Elite SPK Kit is MBI.

其他以 Ncs Lab Srl 為申請人之記錄

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相關器械（代碼：MBI）

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