FDA 510(k)

Linshom 连续预测性呼吸监测系统 (CPRMS)

K号: K250093 · 2025-09-26

决定日期2025-09-26

产品代码BZQ

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决定实质等同

器械摘要

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is the device name listed in this FDA 510(k) record. The listed applicant is Linshom Medical, Inc.. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K250093. 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 Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Linshom Medical, Inc.. The 510(k) number is K250093.

When did Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) receive FDA 510(k) clearance?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250093.

Who is the listed applicant for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

The FDA 510(k) record lists Linshom Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

The FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is BZQ.

列明Linshom Medical, Inc.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。

K240271Linshom 连续预测性呼吸监测系统 (CPRMS)

官方来源

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