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：K210417 · 2021-05-14

決定日期2021-05-14

產品代碼JOW

諮詢委員會履歷

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 2021-05-14 under 510(k) number K210417. The device is classified under product code JOW. It was reviewed by the CV 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 2021-05-14. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K210417.

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 2021-05-14, under 510(k) number K210417.

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 JOW.

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。

K261807連續循環器（SC-4004-DL，SC-4008-DL）K250974生物動脈豪華版（IC-BAP-DX）K213533連續循環器 SC-1004-DL、SC-1008-DL、SC-2004-DL、SC-2008-DL、SC-4004-DL、SC-4008-DL K180248VascuEase IC-1200-WH K171793連續循環器 SC-2004FC-OC

相關器械（代碼：JOW）

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。

K261807連續循環器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLC K253555Flexitouch® Plus 進階氣動壓迫系統Tactile Medical K253386DVT 裝備Vistar Medical Supplies Co., Ltd.K250242壓力治療設備（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

官方來源

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