FDA 510(k)

Root ZX3

K号: K213477 · 2022-08-03

决定日期2022-08-03

产品代码EKZ

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决定实质等同

器械摘要

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.

常见问题

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.

列明J. Morita USA, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K2013783D Accuitomo 150N K190509Lubrina 2 K173920LS OIL K171012Veraview X800 K170275Tri Auto ZX2

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