FDA 510(k)

智慧無線聽診器

K 號：K220470 · 2022-05-23

決定日期2022-05-23

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Smart Wireless Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hulu Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-05-23 under 510(k) number K220470. 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 Smart Wireless Stethoscope?

Smart Wireless Stethoscope is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is Shanghai Hulu Devices Co., Ltd.. The 510(k) number is K220470.

When did Smart Wireless Stethoscope receive FDA 510(k) clearance?

Smart Wireless Stethoscope received FDA 510(k) clearance on 2022-05-23, under 510(k) number K220470.

Who is the listed applicant for Smart Wireless Stethoscope?

FDA 510(k) 記錄將上海漢魯設備有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Smart Wireless Stethoscope?

The FDA product code for Smart Wireless Stethoscope is DQD.

其他以 Shanghai Hulu Devices Co., Ltd. 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。

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）K180335Accutension Smartphone Auscultatory Blood

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

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