FDA 510(k)

Stethee Pro

K 號：K172296 · 2017-10-30

決定日期2017-10-30

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Stethee Pro is the device name listed in this FDA 510(k) record. The listed applicant is M3Dicine Pty , Ltd.. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K172296. 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 Stethee Pro?

Stethee Pro is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is M3Dicine Pty , Ltd.. The 510(k) number is K172296.

When did Stethee Pro receive FDA 510(k) clearance?

Stethee Pro received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172296.

Who is the listed applicant for Stethee Pro?

The FDA 510(k) record lists M3Dicine Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stethee Pro?

The FDA product code for Stethee Pro is DQD.

其他以 M3Dicine Pty , Ltd. 為申請人之記錄

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K193631Stethee Pro 1, Stethee Pro 軟體系統

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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