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FDA 510(k)

eKuore One 電子聽診器介面

K 號:K181882 · 2019-03-27

決定日期2019-03-27
產品代碼DQD
諮詢委員會履歷
決定相當於

器材摘要

eKuore One electronic interface for stethoscope 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 2019-03-27 under 510(k) number K181882. 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 eKuore One electronic interface for stethoscope?

eKuore One electronic interface for stethoscope is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Chip Ideas Electronics S.L.. The 510(k) number is K181882.

When did eKuore One electronic interface for stethoscope receive FDA 510(k) clearance?

eKuore One electronic interface for stethoscope received FDA 510(k) clearance on 2019-03-27, under 510(k) number K181882.

Who is the listed applicant for eKuore One electronic interface for stethoscope?

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 eKuore One electronic interface for stethoscope?

The FDA product code for eKuore One electronic interface for stethoscope is DQD.

相關臨床試驗

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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。

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。

官方來源

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