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FDA 510(k)

c-med0 阿爾法

K 號:K253436 · 2026-04-30

申請人Cosinuss GmbH
決定日期2026-04-30
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

c-med0 alpha is the device name listed in this FDA 510(k) record. The listed applicant is Cosinuss GmbH. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K253436. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the c-med0 alpha?

c-med0 alpha is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Cosinuss GmbH. The 510(k) number is K253436.

When did c-med0 alpha receive FDA 510(k) clearance?

c-med0 alpha received FDA 510(k) clearance on 2026-04-30, under 510(k) number K253436.

Who is the listed applicant for c-med0 alpha?

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

What is the FDA product code for c-med0 alpha?

The FDA product code for c-med0 alpha is MWI.

相關臨床試驗

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相關器械(代碼:MWI)

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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