FDA 510(k)

LD-Oxi系統

K 號：K160956 · 2016-07-06

決定日期2016-07-06

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

LD-Oxi system is the device name listed in this FDA 510(k) record. The listed applicant is Ld Technology, LLC. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K160956. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LD-Oxi system?

LD-Oxi system is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Ld Technology, LLC. The 510(k) number is K160956.

When did LD-Oxi system receive FDA 510(k) clearance?

LD-Oxi system received FDA 510(k) clearance on 2016-07-06, under 510(k) number K160956.

Who is the listed applicant for LD-Oxi system?

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

What is the FDA product code for LD-Oxi system?

The FDA product code for LD-Oxi system is MWI.

其他以 Ld Technology, LLC 為申請人之記錄

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