FDA 510(k)

波威J-Plasma精準FLEX手持器

K 號：K170777 · 2017-05-01

決定日期2017-05-01

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

Bovie J-Plasma Precise FLEX Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K170777. 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 Bovie J-Plasma Precise FLEX Handpiece?

Bovie J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Bovie Medical Corporation. The 510(k) number is K170777.

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

Bovie J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2017-05-01, under 510(k) number K170777.

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

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

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

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

其他以 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。

K183610Renuvion/J-Plasma 精準手持器，Renuvion/J-Plasma 精準開放手持器，Renuvion/J-Plasma 精準開放手持器 K170188波威J-Plasma精準開放式手柄 & 波威終極Gen 2 高頻電外科電流發生器 K161558Bovie 3.3mm 一次性雙極消融器 90°，抽吸和非抽吸型，Bovie 2.4mm 一次性雙極消融器 55°，非抽吸型，Bovie 1.8mm 一次性雙極消融器 60°，非抽吸型 K161134波威Bantam/PRO電外科電流發生器，波威DERM 941電外科電流發生器，波威DERM 942電外科電流發生器 K152777波威一次性雙極消融器

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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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