FDA 510(k)

Apyxヘリウムプラズマジェネレータ（APYX-200H/P、APYX-JS3/RS3）

K番号: K192867 · 2019-10-31

申請者Bovie Medical Corporation Dba Apyx Medical Corporation

決定日2019-10-31

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてBovie Medical Corporation Dba Apyx Medical Corporationを記載するその他の記録

K191542Apyxプラズマ/RFハンドピース

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