FDA 510(k)

FiAPC plus probes

Número K: K243451 · 2025-03-21

Data da decisão2025-03-21

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

FiAPC plus probes is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243451. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FiAPC plus probes?

FiAPC plus probes is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K243451.

When did FiAPC plus probes receive FDA 510(k) clearance?

FiAPC plus probes received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243451.

Who is the listed applicant for FiAPC plus probes?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FiAPC plus probes?

The FDA product code for FiAPC plus probes is GEI.

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Fonte oficial

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