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FDA 510(k)

ReDS系統

K 號：K180479 · 2019-02-28

申請人Sensible Medical Innovations , Ltd.
決定日期2019-02-28
產品代碼DSB
諮詢委員會履歷
決定相當於

器材摘要

ReDS System is the device name listed in this FDA 510(k) record. The listed applicant is Sensible Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2019-02-28 under 510(k) number K180479. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ReDS System?

ReDS System is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Sensible Medical Innovations , Ltd.. The 510(k) number is K180479.

When did ReDS System receive FDA 510(k) clearance?

ReDS System received FDA 510(k) clearance on 2019-02-28, under 510(k) number K180479.

Who is the listed applicant for ReDS System?

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

What is the FDA product code for ReDS System?

The FDA product code for ReDS System is DSB.

相關臨床試驗

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相關器械（代碼：DSB）

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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