FDA 510(k)

顺序压缩系统（SCD600）

K号: K250190 · 2025-12-08

申请人Shenzhen Comen Medical Instruments Co.,Ltd

决定日期2025-12-08

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 Compression System (SCD600) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K250190. 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 Compression System (SCD600)?

Sequential Compression System (SCD600) is a medical device that received FDA 510(k) clearance on 2025-12-08. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K250190.

When did Sequential Compression System (SCD600) receive FDA 510(k) clearance?

Sequential Compression System (SCD600) received FDA 510(k) clearance on 2025-12-08, under 510(k) number K250190.

Who is the listed applicant for Sequential Compression System (SCD600)?

The FDA 510(k) record lists Shenzhen Comen Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sequential Compression System (SCD600)?

The FDA product code for Sequential Compression System (SCD600) is JOW.

列明Shenzhen Comen Medical Instruments Co.,Ltd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。

K250854多参数患者监护仪（N10）；多参数患者监护仪（N12）；多参数患者监护仪（N15）；多参数患者监护仪（N10MPro）；多参数患者监护仪（N12MPro）；多参数患者监护仪（N15MPro）K211619多参数患者监护仪 K191106C50 和 C80 多参数患者监护仪 K173454多参数患者监护仪，型号C30

官方来源

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