FDA 510(k)

Radical-7 脉冲血氧计及其附件，Rad-97 及其附件

K号: K212161 · 2023-03-06

决定日期2023-03-06

产品代码MWI

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

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K212161. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Masimo Corporation. The 510(k) number is K212161.

When did Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories receive FDA 510(k) clearance?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories received FDA 510(k) clearance on 2023-03-06, under 510(k) number K212161.

Who is the listed applicant for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

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 Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

The FDA product code for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is MWI.

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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