FDA 510(k)

波坦扎

K 號：K192545 · 2020-02-20

決定日期2020-02-20

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

Potenza is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K192545. 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 Potenza?

Potenza is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K192545.

When did Potenza receive FDA 510(k) clearance?

Potenza received FDA 510(k) clearance on 2020-02-20, under 510(k) number K192545.

Who is the listed applicant for Potenza?

FDA 510(k) 記錄將 Jeisys Medical Incorporated 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Potenza?

The FDA product code for Potenza is GEI.

其他以 Jeisys Medical Incorporated 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。

K254185波坦茲·普瑞美 K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG 激光單元)K250065濃度；Denza；DENSITY Noir

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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官方來源

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