FDA 510(k)

SedLine Sedation Monitor

K号: K260880 · 2026-07-10

决定日期2026-07-10

产品代码OLW

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决定实质等同

器械摘要

SedLine Sedation Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K260880. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SedLine Sedation Monitor?

SedLine Sedation Monitor is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Masimo Corporation. The 510(k) number is K260880.

When did SedLine Sedation Monitor receive FDA 510(k) clearance?

SedLine Sedation Monitor received FDA 510(k) clearance on 2026-07-10, under 510(k) number K260880.

Who is the listed applicant for SedLine Sedation Monitor?

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 SedLine Sedation Monitor?

The FDA product code for SedLine Sedation Monitor is OLW.

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 K254209Radius VSM和附件 K243324Masimo O3 区域脉搏血氧仪 K250757Radius VSM和附件 K243305Masimo W1 K240229Masimo 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。