Respiree 心肺呼吸监测仪
K号: K223681 · 2023-03-08
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决定日期2023-03-08
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
Respiree Cardio-Respiratory Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Respiree Pte, Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K223681. 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 Respiree Cardio-Respiratory Monitor?
Respiree Cardio-Respiratory Monitor is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Respiree Pte, Ltd.. The 510(k) number is K223681.
When did Respiree Cardio-Respiratory Monitor receive FDA 510(k) clearance?
Respiree Cardio-Respiratory Monitor received FDA 510(k) clearance on 2023-03-08, under 510(k) number K223681.
Who is the listed applicant for Respiree Cardio-Respiratory Monitor?
The FDA 510(k) record lists Respiree Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Respiree Cardio-Respiratory Monitor?
The FDA product code for Respiree Cardio-Respiratory Monitor is BZQ.
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列明Respiree Pte, Ltd.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。
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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