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FDA 510(k)

Creavo Vitalscan 靜磁心電圖機

K 號:K170154 · 2017-10-12

決定日期2017-10-12
產品代碼DPS
諮詢委員會履歷
決定相當於

器材摘要

Creavo Vitalscan Magnetocardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Creavo Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170154. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Creavo Vitalscan Magnetocardiograph?

Creavo Vitalscan Magnetocardiograph is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Creavo Medical Technologies, Ltd.. The 510(k) number is K170154.

When did Creavo Vitalscan Magnetocardiograph receive FDA 510(k) clearance?

Creavo Vitalscan Magnetocardiograph received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170154.

Who is the listed applicant for Creavo Vitalscan Magnetocardiograph?

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

What is the FDA product code for Creavo Vitalscan Magnetocardiograph?

The FDA product code for Creavo Vitalscan Magnetocardiograph is DPS.

相關臨床試驗

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相關器械(代碼:DPS)

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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