FDA 510(k)

Apyx 等离子体/射频手柄

K号: K191542 · 2019-10-11

申请人Bovie Medical Corporation Dba Apyx Medical Corporation

决定日期2019-10-11

产品代码GEI

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决定实质等同

器械摘要

Apyx Plasma/RF Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation Dba Apyx Medical Corporation. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191542. 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 Plasma/RF Handpiece?

Apyx Plasma/RF Handpiece is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Bovie Medical Corporation Dba Apyx Medical Corporation. The 510(k) number is K191542.

When did Apyx Plasma/RF Handpiece receive FDA 510(k) clearance?

Apyx Plasma/RF Handpiece received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191542.

Who is the listed applicant for Apyx Plasma/RF Handpiece?

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

What is the FDA product code for Apyx Plasma/RF Handpiece?

The FDA product code for Apyx Plasma/RF Handpiece is GEI.

列明Bovie Medical Corporation Dba 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。

K192867Apyx 氦等离子体发生器 (APYX-200H/P, APYX-JS3/RS3)

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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