FDA 510(k)

根ZX3

K 號：K213477 · 2022-08-03

決定日期2022-08-03

產品代碼EKZ

諮詢委員會DE

決定相當於

器材摘要

Root ZX3 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 2022-08-03 under 510(k) number K213477. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Root ZX3?

Root ZX3 is a medical device that received FDA 510(k) clearance on 2022-08-03. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K213477.

When did Root ZX3 receive FDA 510(k) clearance?

Root ZX3 received FDA 510(k) clearance on 2022-08-03, under 510(k) number K213477.

Who is the listed applicant for Root ZX3?

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 Root ZX3?

The FDA product code for Root ZX3 is EKZ.

其他以 J. Morita USA, Inc. 為申請人之記錄

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