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FDA 510(k)

連續循環器 SC-1004-DL、SC-1008-DL、SC-2004-DL、SC-2008-DL、SC-4004-DL、SC-4008-DL

K 號:K213533 · 2022-02-16

決定日期2022-02-16
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is the device name listed in this FDA 510(k) record. The listed applicant is Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2022-02-16 under 510(k) number K213533. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is a medical device that received FDA 510(k) clearance on 2022-02-16. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K213533.

When did Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL receive FDA 510(k) clearance?

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL received FDA 510(k) clearance on 2022-02-16, under 510(k) number K213533.

Who is the listed applicant for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

FDA 510(k) 記錄將 Bio Compression Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL?

The FDA product code for Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL is IRP.

相關臨床試驗

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。

其他以 Bio Compression Systems, Inc. 為申請人之記錄

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。

相關器械(代碼:IRP)

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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