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FDA 510(k)

LEONI ORION 系統

K 號：K160518 · 2016-07-14

申請人Leoni Cia Cable System
決定日期2016-07-14
產品代碼JAI
諮詢委員會RA
決定相當於

器材摘要

LEONI ORION System is the device name listed in this FDA 510(k) record. The listed applicant is Leoni Cia Cable System. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160518. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LEONI ORION System?

LEONI ORION System is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Leoni Cia Cable System. The 510(k) number is K160518.

When did LEONI ORION System receive FDA 510(k) clearance?

LEONI ORION System received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160518.

Who is the listed applicant for LEONI ORION System?

The FDA 510(k) record lists Leoni Cia Cable System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEONI ORION System?

The FDA product code for LEONI ORION System is JAI.

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相關器械（代碼：JAI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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