FDA 510(k)

呼吸频率算法

K号: K251326 · 2026-06-11

决定日期2026-06-11

产品代码BZQ

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决定实质等同

器械摘要

Respiration Rate algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K251326. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Respiration Rate algorithm?

Respiration Rate algorithm is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251326.

When did Respiration Rate algorithm receive FDA 510(k) clearance?

Respiration Rate algorithm received FDA 510(k) clearance on 2026-06-11, under 510(k) number K251326.

Who is the listed applicant for Respiration Rate algorithm?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respiration Rate algorithm?

The FDA product code for Respiration Rate algorithm is BZQ.

列明Edwards Lifesciences, 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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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。