FDA 510(k)

Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

K号: K210417 · 2021-05-14

决定日期2021-05-14

产品代码JOW

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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)记录显示，Bio Compression Systems, Inc.为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Bio Compression Systems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261807顺序循环器（SC-4004-DL，SC-4008-DL）K250974Bio Arterial Deluxe (IC-BAP-DX)K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL K180248VascuEase IC-1200-WH K171793Sequential Circulator SC-2004FC-OC

官方来源

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