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FDA 510(k)

Mini Ridge Filter and auxiliary functions for PROBEAT-V

N.º K: K181676 · 2018-08-15

SolicitanteHitachi Ltd. Healthcare Hitachi Works
Fecha de decisión2018-08-15
Código de productoLHN
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Mini Ridge Filter and auxiliary functions for PROBEAT-V is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Ltd. Healthcare Hitachi Works. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181676. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Mini Ridge Filter and auxiliary functions for PROBEAT-V?

Mini Ridge Filter and auxiliary functions for PROBEAT-V is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Hitachi Ltd. Healthcare Hitachi Works. The 510(k) number is K181676.

When did Mini Ridge Filter and auxiliary functions for PROBEAT-V receive FDA 510(k) clearance?

Mini Ridge Filter and auxiliary functions for PROBEAT-V received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181676.

Who is the listed applicant for Mini Ridge Filter and auxiliary functions for PROBEAT-V?

The FDA 510(k) record lists Hitachi Ltd. Healthcare Hitachi Works as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini Ridge Filter and auxiliary functions for PROBEAT-V?

The FDA product code for Mini Ridge Filter and auxiliary functions for PROBEAT-V is LHN.

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Dispositivos relacionados (Código: LHN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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