FDA 510(k)

PROBEAT-CR

Número K: K260174 · 2026-06-11

Data da decisão2026-06-11

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

PROBEAT-CR is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi High-Tech Corp.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260174. 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 PROBEAT-CR?

PROBEAT-CR is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Hitachi High-Tech Corp.. The 510(k) number is K260174.

When did PROBEAT-CR receive FDA 510(k) clearance?

PROBEAT-CR received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260174.

Who is the listed applicant for PROBEAT-CR?

The FDA 510(k) record lists Hitachi High-Tech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBEAT-CR?

The FDA product code for PROBEAT-CR is LHN.

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