FDA 510(k)

RFG-01

K 號：K240178 · 2024-07-15

決定日期2024-07-15

產品代碼PBX

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

RFG-01 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2024-07-15 under 510(k) number K240178. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RFG-01?

RFG-01 is a medical device that received FDA 510(k) clearance on 2024-07-15. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K240178.

When did RFG-01 receive FDA 510(k) clearance?

RFG-01 received FDA 510(k) clearance on 2024-07-15, under 510(k) number K240178.

Who is the listed applicant for RFG-01?

The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RFG-01?

The FDA product code for RFG-01 is PBX.

其他以 Zimmer Medizinsysteme GmbH 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。

K253408涼頻 K251378涼頻 K240347PTG-05 K230780MFG-05 K213256ThermoTK K222912c1Trac

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相關器械（代碼：PBX）

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。

K243223多療法美容治療設備（BHS 202 UNYQUE）Bh Group Us, LLC K253480Capenergy C 裝置 RF C200 及 C400 DrakarianCapenergy Medical S.L.K260647規範化醫療設備名稱：SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV 裝置Pollogen, Ltd.

官方來源

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