FDA 510(k)

Capnostream™35 便携式呼吸监测仪 (PM35MN)

K号: K253030 · 2026-05-01

决定日期2026-05-01

产品代码CCK

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决定实质等同

器械摘要

Capnostream™35 Portable Respiratory Monitor (PM35MN) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K253030. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Capnostream™35 Portable Respiratory Monitor (PM35MN)?

Capnostream™35 Portable Respiratory Monitor (PM35MN) is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Covidien, LLC. The 510(k) number is K253030.

When did Capnostream™35 Portable Respiratory Monitor (PM35MN) receive FDA 510(k) clearance?

Capnostream™35 Portable Respiratory Monitor (PM35MN) received FDA 510(k) clearance on 2026-05-01, under 510(k) number K253030.

Who is the listed applicant for Capnostream™35 Portable Respiratory Monitor (PM35MN)?

FDA 510(k)记录中列出Covidien, LLC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 Capnostream™35 Portable Respiratory Monitor (PM35MN)?

The FDA product code for Capnostream™35 Portable Respiratory Monitor (PM35MN) is CCK.

列明Covidien, LLC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。

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