FDA 510(k)

RGS；RGS迷你

K 號：K222702 · 2023-06-02

決定日期2023-06-02

產品代碼FRA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

RGS; RGS Mini is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Air, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222702. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RGS; RGS Mini?

RGS; RGS Mini is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Genesis Air, Inc.. The 510(k) number is K222702.

When did RGS; RGS Mini receive FDA 510(k) clearance?

RGS; RGS Mini received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222702.

Who is the listed applicant for RGS; RGS Mini?

The FDA 510(k) record lists Genesis Air, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RGS; RGS Mini?

The FDA product code for RGS; RGS Mini is FRA.

相關器械（代碼：FRA）

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。

K252128Zener®（型號 ZEN-001-B1）Uvx, Inc.K241140ViroZap 室內空氣淨化器，風管型號 1008Applied Photonix, LLC K232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle 房間空氣淨化器Airgle Corporation K221540Synexis Sphere RxSynexis, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。