FDA 510(k)

核心500數位聽診器

K 號：K233609 · 2024-03-28

決定日期2024-03-28

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

CORE 500 Digital Stethoscope 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 2024-03-28 under 510(k) number K233609. 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 CORE 500 Digital Stethoscope?

CORE 500 Digital Stethoscope is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Eko Health, Inc.. The 510(k) number is K233609.

When did CORE 500 Digital Stethoscope receive FDA 510(k) clearance?

CORE 500 Digital Stethoscope received FDA 510(k) clearance on 2024-03-28, under 510(k) number K233609.

Who is the listed applicant for CORE 500 Digital Stethoscope?

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 CORE 500 Digital Stethoscope?

The FDA product code for CORE 500 Digital Stethoscope 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 K251494Eko Foundation 分析軟體搭配 Transformer (EFAST)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。

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官方來源

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