FDA 510(k)

MagnetOs MIS

Número K: K243474 · 2025-05-23

Data da decisão2025-05-23

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MagnetOs MIS is the device name listed in this FDA 510(k) record. The listed applicant is Kuros Biosciences B.V. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K243474. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MagnetOs MIS?

MagnetOs MIS is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Kuros Biosciences B.V. The 510(k) number is K243474.

When did MagnetOs MIS receive FDA 510(k) clearance?

MagnetOs MIS received FDA 510(k) clearance on 2025-05-23, under 510(k) number K243474.

Who is the listed applicant for MagnetOs MIS?

The FDA 510(k) record lists Kuros Biosciences B.V as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagnetOs MIS?

The FDA product code for MagnetOs MIS is MQV.

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K240442MagnetOs Putty K232347MagnetOs Granules K230736MagnetOs Putty K233607MagnetOs Easypack Putty K233245MagnetOs Flex Matrix K213959MagnetOs Flex Matrix

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Fonte oficial

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