Linshom 呼吸监测设备 (LRMD)
K号: K190734 · 2020-01-30
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决定日期2020-01-30
产品代码BZQ
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
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器械摘要
Linshom Respiratory Monitoring Device (LRMD) is the device name listed in this FDA 510(k) record. The listed applicant is Linshom Management, LLC. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K190734. 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 Respiratory Monitoring Device (LRMD)?
Linshom Respiratory Monitoring Device (LRMD) is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Linshom Management, LLC. The 510(k) number is K190734.
When did Linshom Respiratory Monitoring Device (LRMD) receive FDA 510(k) clearance?
Linshom Respiratory Monitoring Device (LRMD) received FDA 510(k) clearance on 2020-01-30, under 510(k) number K190734.
Who is the listed applicant for Linshom Respiratory Monitoring Device (LRMD)?
The FDA 510(k) record lists Linshom Management, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Linshom Respiratory Monitoring Device (LRMD)?
The FDA product code for Linshom Respiratory Monitoring Device (LRMD) is BZQ.
相关临床试验
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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。
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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