FDA 510(k)

Masimo O3 区域脉搏血氧仪系统

K号: K214072 · 2022-05-06

决定日期2022-05-06

产品代码MUD

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 O3 Regional Oximeter System is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K214072. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Masimo O3 Regional Oximeter System?

Masimo O3 Regional Oximeter System is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Masimo Corporation. The 510(k) number is K214072.

When did Masimo O3 Regional Oximeter System receive FDA 510(k) clearance?

Masimo O3 Regional Oximeter System received FDA 510(k) clearance on 2022-05-06, under 510(k) number K214072.

Who is the listed applicant for Masimo O3 Regional Oximeter System?

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 O3 Regional Oximeter System?

The FDA product code for Masimo O3 Regional Oximeter System is MUD.

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 K243305Masimo W1

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官方来源

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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。