RTMsense 呼吸监测系统
K号: K243183 · 2025-06-27
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决定日期2025-06-27
产品代码BZQ
咨询委员会AN
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决定实质等同
器械摘要
RTMsense Respiratory Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Rtm Vital Signs, LLC. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243183. 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 RTMsense Respiratory Monitoring System?
RTMsense Respiratory Monitoring System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Rtm Vital Signs, LLC. The 510(k) number is K243183.
When did RTMsense Respiratory Monitoring System receive FDA 510(k) clearance?
RTMsense Respiratory Monitoring System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243183.
Who is the listed applicant for RTMsense Respiratory Monitoring System?
The FDA 510(k) record lists Rtm Vital Signs, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RTMsense Respiratory Monitoring System?
The FDA product code for RTMsense Respiratory Monitoring System is BZQ.
相关临床试验
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。
相关器械（代码：BZQ）
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。
K253274BedDot (G1)Intelligent Dots, LLCK251326呼吸频率算法Edwards Lifesciences, LLCK250093Linshom 连续预测性呼吸监测系统 (CPRMS)Linshom Medical, Inc.K250934Respiree 心肺呼吸监测系统Respiree Pte, Ltd.K243966FaceHeart Vitals 软件开发工具包（FH vitals SDK-RR）Faceheart Corp.K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.
官方来源
在 FDA 数据库中查看 →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。
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