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FDA 510(k)

J-Plasma精準FLEX手持式器具

K 號：K202880 · 2021-01-04

申請人Apyx Medical Corporation (Formerly Bovie Medical Corporation
決定日期2021-01-04
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

J-Plasma Precise FLEX Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. It received FDA 510(k) clearance on 2021-01-04 under 510(k) number K202880. 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 J-Plasma Precise FLEX Handpiece?

J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2021-01-04. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K202880.

When did J-Plasma Precise FLEX Handpiece receive FDA 510(k) clearance?

J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2021-01-04, under 510(k) number K202880.

Who is the listed applicant for J-Plasma Precise FLEX Handpiece?

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

What is the FDA product code for J-Plasma Precise FLEX Handpiece?

The FDA product code for J-Plasma Precise FLEX Handpiece is GEI.

相關臨床試驗

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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其他以 Apyx Medical Corporation (Formerly Bovie 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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官方來源

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