FDA 510(k)

Eko Foundation 分析軟體搭配 Transformer (EFAST)

K 號：K251494 · 2025-08-12

決定日期2025-08-12

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Eko Foundation Analysis Software with Transformers (EFAST) is the device name listed in this FDA 510(k) record. The listed applicant is Eko Health, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K251494. 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 Eko Foundation Analysis Software with Transformers (EFAST)?

Eko Foundation Analysis Software with Transformers (EFAST) is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Eko Health, Inc.. The 510(k) number is K251494.

When did Eko Foundation Analysis Software with Transformers (EFAST) receive FDA 510(k) clearance?

Eko Foundation Analysis Software with Transformers (EFAST) received FDA 510(k) clearance on 2025-08-12, under 510(k) number K251494.

Who is the listed applicant for Eko Foundation Analysis Software with Transformers (EFAST)?

FDA 510(k) 記錄將 Eko Health, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Eko Foundation Analysis Software with Transformers (EFAST)?

The FDA product code for Eko Foundation Analysis Software with Transformers (EFAST) is DQD.

其他以 Eko Health, Inc. 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。

K261694核心300數位聽診器 K233609核心500數位聽診器 K233409Eko 低射血量工具 (ELEFT)

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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