FDA 510(k)

Apyx 氦等离子體發生器 (APYX-200H/P, APYX-JS3/RS3)

K 號：K192867 · 2019-10-31

申請人Bovie Medical Corporation Dba Apyx Medical Corporation

決定日期2019-10-31

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) 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 2019-10-31 under 510(k) number K192867. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)?

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) is a medical device that received FDA 510(k) clearance on 2019-10-31. The listed applicant is Bovie Medical Corporation Dba Apyx Medical Corporation. The 510(k) number is K192867.

When did Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) receive FDA 510(k) clearance?

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) received FDA 510(k) clearance on 2019-10-31, under 510(k) number K192867.

Who is the listed applicant for Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)?

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 Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)?

The FDA product code for Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) is GEI.

其他以 Bovie Medical Corporation Dba Apyx Medical Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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