Breathe Easy Mobile Respiratory Monitor (MRM)
K号: K211387 · 2021-11-23
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决定日期2021-11-23
产品代码BZQ
咨询委员会AN
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器械摘要
Breathe Easy Mobile Respiratory Monitor (MRM) is the device name listed in this FDA 510(k) record. The listed applicant is Sound Life Sciences, Inc.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211387. 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 Breathe Easy Mobile Respiratory Monitor (MRM)?
Breathe Easy Mobile Respiratory Monitor (MRM) is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Sound Life Sciences, Inc.. The 510(k) number is K211387.
When did Breathe Easy Mobile Respiratory Monitor (MRM) receive FDA 510(k) clearance?
Breathe Easy Mobile Respiratory Monitor (MRM) received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211387.
Who is the listed applicant for Breathe Easy Mobile Respiratory Monitor (MRM)?
The FDA 510(k) record lists Sound Life Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM)?
The FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM) 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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