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FDA 510(k)

微趨系統

K 號:K212425 · 2024-11-07

決定日期2024-11-07
產品代碼CCK
諮詢委員會AN
決定相當於

器材摘要

MicroTrend System is the device name listed in this FDA 510(k) record. The listed applicant is Exostat Medical, Inc.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K212425. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MicroTrend System?

MicroTrend System is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Exostat Medical, Inc.. The 510(k) number is K212425.

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

MicroTrend System received FDA 510(k) clearance on 2024-11-07, under 510(k) number K212425.

Who is the listed applicant for MicroTrend System?

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

What is the FDA product code for MicroTrend System?

The FDA product code for MicroTrend System is CCK.

相關臨床試驗

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相關器械(代碼:CCK)

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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