FDA 510(k)

MDHearingAid 聽力輔助應用程式，MDHearingAid 智能聽力輔助器

K 號：K220303 · 2022-08-04

決定日期2022-08-04

產品代碼QDD

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

MDHearingAid app, MDHearingAid Smart hearing aids is the device name listed in this FDA 510(k) record. The listed applicant is Mdhearingaid. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K220303. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MDHearingAid app, MDHearingAid Smart hearing aids?

MDHearingAid app, MDHearingAid Smart hearing aids is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Mdhearingaid. The 510(k) number is K220303.

When did MDHearingAid app, MDHearingAid Smart hearing aids receive FDA 510(k) clearance?

MDHearingAid app, MDHearingAid Smart hearing aids received FDA 510(k) clearance on 2022-08-04, under 510(k) number K220303.

Who is the listed applicant for MDHearingAid app, MDHearingAid Smart hearing aids?

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

What is the FDA product code for MDHearingAid app, MDHearingAid Smart hearing aids?

The FDA product code for MDHearingAid app, MDHearingAid Smart hearing aids is QDD.

相關器械（代碼：QDD）

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。

K223911Lumen 155-SFIntricon Corporation K220403Vibe SF 自適應聽力輔助設備Wsaud A/S K213424Jabra Enhance PlusGN Hearing A/S K212609BHA100系列布蘭德潔淨聽力輔助器Kaz USA, Inc., A Helen of Troy Company K211008Bose SoundControl 聽力輔助設備Bose Corporation

官方來源

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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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：QDD）

官方來源