FDA 510(k)

HybridAPC probe

Número K: K243120 · 2025-06-20

Data da decisão2025-06-20

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HybridAPC probe 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 2025-06-20 under 510(k) number K243120. 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 HybridAPC probe?

HybridAPC probe is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K243120.

When did HybridAPC probe receive FDA 510(k) clearance?

HybridAPC probe received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243120.

Who is the listed applicant for HybridAPC probe?

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 HybridAPC probe?

The FDA product code for HybridAPC probe is GEI.

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Fonte oficial

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