FDA 510(k)

BEE HA

Número K: K250560 · 2025-11-21

Data da decisão2025-11-21

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BEE HA is the device name listed in this FDA 510(k) record. The listed applicant is NGMedical GmbH. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K250560. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BEE HA?

BEE HA is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is NGMedical GmbH. The 510(k) number is K250560.

When did BEE HA receive FDA 510(k) clearance?

BEE HA received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250560.

Who is the listed applicant for BEE HA?

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

What is the FDA product code for BEE HA?

The FDA product code for BEE HA is ODP.

Outros registros que listam NGMedical GmbH como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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