FDA 510(k)

MA-40, MA-112

K 號：K223835 · 2023-09-18

決定日期2023-09-18

產品代碼FRF

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

MA-40, MA-112 is the device name listed in this FDA 510(k) record. The listed applicant is Medify Air, LLC. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K223835. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MA-40, MA-112?

MA-40, MA-112 is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Medify Air, LLC. The 510(k) number is K223835.

When did MA-40, MA-112 receive FDA 510(k) clearance?

MA-40, MA-112 received FDA 510(k) clearance on 2023-09-18, under 510(k) number K223835.

Who is the listed applicant for MA-40, MA-112?

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

What is the FDA product code for MA-40, MA-112?

The FDA product code for MA-40, MA-112 is FRF.

相關器械（代碼：FRF）

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。

K251872生物幣阿瓦塔RxBiomoneta Research Private Limited K242102CerroZone MiniCerrozone, LLC K240696Airdog X8空氣淨化器(KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd.K222416RIA保護措施Ria Tech Co., Ltd.K211507Airdog X5循環空氣淨化器(型號KJ300F-X5)Beiang Air Tech , Ltd.K220990Qorda QD1Winix, Inc.

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。