FDA 510(k)

eMurmur Heart AI

K 號：K220766 · 2022-05-31

決定日期2022-05-31

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

eMurmur Heart AI is the device name listed in this FDA 510(k) record. The listed applicant is Csd Labs GmbH. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K220766. 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 eMurmur Heart AI?

eMurmur Heart AI is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Csd Labs GmbH. The 510(k) number is K220766.

When did eMurmur Heart AI receive FDA 510(k) clearance?

eMurmur Heart AI received FDA 510(k) clearance on 2022-05-31, under 510(k) number K220766.

Who is the listed applicant for eMurmur Heart AI?

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

What is the FDA product code for eMurmur Heart AI?

The FDA product code for eMurmur Heart AI is DQD.

其他以 Csd Labs GmbH 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。

K181988eMurmur ID

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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