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FDA 510(k)

關於Balans醫療設備規範文本 Re:Balans

K 號：K243727 · 2025-10-16

申請人Mode Sensors AS
決定日期2025-10-16
產品代碼DSB
諮詢委員會履歷
決定相當於

器材摘要

Re:Balans is the device name listed in this FDA 510(k) record. The listed applicant is Mode Sensors AS. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K243727. 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 Re:Balans?

Re:Balans is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Mode Sensors AS. The 510(k) number is K243727.

When did Re:Balans receive FDA 510(k) clearance?

Re:Balans received FDA 510(k) clearance on 2025-10-16, under 510(k) number K243727.

Who is the listed applicant for Re:Balans?

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

What is the FDA product code for Re:Balans?

The FDA product code for Re:Balans 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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