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FDA 510(k)

Cardiologs Holter Platform

K 號:K250569 · 2025-08-06

決定日期2025-08-06
產品代碼DPS
諮詢委員會CV
決定Substantially Equivalent

器材摘要

Cardiologs Holter Platform is the device name listed in this FDA 510(k) record. The listed applicant is Philips France Commercial. It received FDA 510(k) clearance on 2025-08-06 under 510(k) number K250569. 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 Cardiologs Holter Platform?

Cardiologs Holter Platform is a medical device that received FDA 510(k) clearance on 2025-08-06. The listed applicant is Philips France Commercial. The 510(k) number is K250569.

When did Cardiologs Holter Platform receive FDA 510(k) clearance?

Cardiologs Holter Platform received FDA 510(k) clearance on 2025-08-06, under 510(k) number K250569.

Who is the listed applicant for Cardiologs Holter Platform?

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

What is the FDA product code for Cardiologs Holter Platform?

The FDA product code for Cardiologs Holter Platform 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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