Vivo 45 LS
K号: K233452 · 2025-01-13
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决定日期2025-01-13
产品代码NOU
咨询委员会AN
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器械摘要
Vivo 45 LS is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K233452. The device is classified under product code NOU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vivo 45 LS?
Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Breas Medical AB. The 510(k) number is K233452.
When did Vivo 45 LS receive FDA 510(k) clearance?
Vivo 45 LS received FDA 510(k) clearance on 2025-01-13, under 510(k) number K233452.
Who is the listed applicant for Vivo 45 LS?
The FDA 510(k) record lists Breas Medical AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vivo 45 LS?
The FDA product code for Vivo 45 LS is NOU.
列明Breas Medical AB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：NOU）
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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