FDA 510(k)

Mini Ridge Filter and auxiliary functions for PROBEAT-V

Número K: K181676 · 2018-08-15

RequerenteHitachi Ltd. Healthcare Hitachi Works

Data da decisão2018-08-15

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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