FDA 510(k)

三自動ZX2

K 號：K170275 · 2017-09-11

決定日期2017-09-11

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

Tri Auto ZX2 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K170275. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tri Auto ZX2?

Tri Auto ZX2 is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K170275.

When did Tri Auto ZX2 receive FDA 510(k) clearance?

Tri Auto ZX2 received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170275.

Who is the listed applicant for Tri Auto ZX2?

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

What is the FDA product code for Tri Auto ZX2?

The FDA product code for Tri Auto ZX2 is EKX.

其他以 J. Morita USA, Inc. 為申請人之記錄

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相關器械（代碼：EKX）

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官方來源

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