FDA 510(k)

Masimo W1

K号: K243305 · 2025-04-03

决定日期2025-04-03

产品代码DPS

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

Masimo W1 is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K243305. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Masimo W1?

Masimo W1 is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Masimo Corporation. The 510(k) number is K243305.

When did Masimo W1 receive FDA 510(k) clearance?

Masimo W1 received FDA 510(k) clearance on 2025-04-03, under 510(k) number K243305.

Who is the listed applicant for Masimo W1?

FDA 510(k)记录显示Masimo公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Masimo W1?

The FDA product code for Masimo W1 is DPS.

列明Masimo Corporation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。

K253417Masimo 根部监测系统 K260880SedLine Sedation Monitor K254209Radius VSM和附件 K243324Masimo O3 区域脉搏血氧仪 K250757Radius VSM和附件 K240229Masimo W1

查看所有 42 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。