FDA 510(k)

MBT 컴패스 HT CA 소프트웨어; MBT 패스트 셔틀 US IVD

K-번호: K251495 · 2025-08-13

결정일2025-08-13

제품 코드QBN

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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MBT 컴패스 HT CA 소프트웨어; MBT 패스트 셔틀 US IVD

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: QBN)

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