MBT Compass HT CA Software; MBT FAST Shuttle US IVD
K号: K251495 · 2025-08-13
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决定日期2025-08-13
产品代码QBN
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器械摘要
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonics GmbH & Co. KG. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K251495. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Bruker Daltonics GmbH & Co. KG. The 510(k) number is K251495.
When did MBT Compass HT CA Software; MBT FAST Shuttle US IVD receive FDA 510(k) clearance?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251495.
Who is the listed applicant for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
The FDA 510(k) record lists Bruker Daltonics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
The FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD is QBN.
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：QBN）
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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