免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

ES001 適用於一般聽診的數位聽診器，ES002 適用於聽障用戶的數位聽診器，ES003 適用於遠程醫療的數位聽診器。

K 號：K211779 · 2022-05-26

申請人Chip Ideas Electronics S.L.
決定日期2022-05-26
產品代碼DQD
諮詢委員會履歷
決定相當於

器材摘要

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is the device name listed in this FDA 510(k) record. The listed applicant is Chip Ideas Electronics S.L.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K211779. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.?

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Chip Ideas Electronics S.L.. The 510(k) number is K211779.

When did ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. receive FDA 510(k) clearance?

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. received FDA 510(k) clearance on 2022-05-26, under 510(k) number K211779.

Who is the listed applicant for ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.?

The FDA 510(k) record lists Chip Ideas Electronics S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.?

The FDA product code for ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is DQD.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Chip Ideas Electronics S.L. 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。

K212013eKuore Pro 4T - 參考編號 EP0098K201742eKuore One 電子聽診器無線介面K203007eKuore Pro 系列K181882eKuore One 電子聽診器介面

相關器械（代碼：DQD）

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。

K261494智慧無線聽診器（STEMO310）；智慧無線聽診器（STEMO710）；智慧無線聽診器（STEMO720）；智慧無線聽診器（STEMO730）Shanghai Hulu Devices Co., Ltd.K261694核心300數位聽診器Eko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089泰托聽診器（G3）Tyto Care , Ltd.K252076膝聲軟骨評估系統（750-3600-001）Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

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。

↑