康莎索聽力輔助設備（CL-1001）
K 號：K233747 · 2024-03-15
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申請人Concha Labs
決定日期2024-03-15
產品代碼QUH
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
Concha Sol Hearing Aids (CL-1001) is the device name listed in this FDA 510(k) record. The listed applicant is Concha Labs. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K233747. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Concha Sol Hearing Aids (CL-1001)?
Concha Sol Hearing Aids (CL-1001) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Concha Labs. The 510(k) number is K233747.
When did Concha Sol Hearing Aids (CL-1001) receive FDA 510(k) clearance?
Concha Sol Hearing Aids (CL-1001) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K233747.
Who is the listed applicant for Concha Sol Hearing Aids (CL-1001)?
The FDA 510(k) record lists Concha Labs as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Concha Sol Hearing Aids (CL-1001)?
The FDA product code for Concha Sol Hearing Aids (CL-1001) is QUH.
相關臨床試驗
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。
相關器械（代碼：QUH）
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。
K254108Jabra Enhance Select 自選配 (Jabra Enhance Select 550)GN Hearing A/SK233464WSA 自適應式聽力輔助器 第2代Wsaud A/SK231550Sontro® 非處方用聽力輔助設備（AI）Soundwave Hearing, LLCK221052自適應式聽力輔助器Huizhou Jinghao Medical Technology Co., Ltd.K223848Intrisound™ 調節光輻® 155 聽力輔助器Tuned , Ltd.K230538All-Day Clear Slim ADCS1 聽力辅助器。All-Day Clear ADC1 聽力辅助器Sonova AG
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。
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