FDA 510(k)

電子聽診器 DS301

K 號：K160023 · 2016-09-30

決定日期2016-09-30

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Electronic Stethoscope DS301 is the device name listed in this FDA 510(k) record. The listed applicant is Imediplus, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K160023. 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 Electronic Stethoscope DS301?

Electronic Stethoscope DS301 is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Imediplus, Inc.. The 510(k) number is K160023.

When did Electronic Stethoscope DS301 receive FDA 510(k) clearance?

Electronic Stethoscope DS301 received FDA 510(k) clearance on 2016-09-30, under 510(k) number K160023.

Who is the listed applicant for Electronic Stethoscope DS301?

The FDA 510(k) record lists Imediplus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Stethoscope DS301?

The FDA product code for Electronic Stethoscope DS301 is DQD.

其他以 Imediplus, 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。

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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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