FDA 510(k)

Apyx 一体机控制台

K号: K221830 · 2022-10-11

决定日期2022-10-11

产品代码GEI

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决定实质等同

器械摘要

Apyx One Console is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation. It received FDA 510(k) clearance on 2022-10-11 under 510(k) number K221830. 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 Apyx One Console?

Apyx One Console is a medical device that received FDA 510(k) clearance on 2022-10-11. The listed applicant is Apyx Medical Corporation. The 510(k) number is K221830.

When did Apyx One Console receive FDA 510(k) clearance?

Apyx One Console received FDA 510(k) clearance on 2022-10-11, under 510(k) number K221830.

Who is the listed applicant for Apyx One Console?

FDA 510(k)记录列出了Apyx Medical Corporation为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Apyx One Console?

The FDA product code for Apyx One Console is GEI.

列明Apyx Medical 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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