FDA 510(k)

Voyant Maryland融合设备（单步激活，EB212，EB213，EB214）

K号: K222284 · 2022-10-14

申请人Applied Medical Resources Corporation

决定日期2022-10-14

产品代码GEI

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决定实质等同

器械摘要

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K222284. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K222284.

When did Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) receive FDA 510(k) clearance?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) received FDA 510(k) clearance on 2022-10-14, under 510(k) number K222284.

Who is the listed applicant for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

The FDA product code for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is GEI.

列明Applied Medical Resources Corporation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。

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相关器械（代码：GEI）

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。

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