FDA 510(k)

Duet Apollo (Modelo: APD-4000)

Número K: K212253 · 2022-08-25

Data da decisão2022-08-25

Código do produtoPBX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apollo Duet (Model : APD-4000) is the device name listed in this FDA 510(k) record. The listed applicant is Weero Co.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K212253. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Apollo Duet (Model : APD-4000)?

Apollo Duet (Model : APD-4000) is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Weero Co.. The 510(k) number is K212253.

When did Apollo Duet (Model : APD-4000) receive FDA 510(k) clearance?

Apollo Duet (Model : APD-4000) received FDA 510(k) clearance on 2022-08-25, under 510(k) number K212253.

Who is the listed applicant for Apollo Duet (Model : APD-4000)?

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

What is the FDA product code for Apollo Duet (Model : APD-4000)?

The FDA product code for Apollo Duet (Model : APD-4000) is PBX.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: PBX)

K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Quattro Apollo (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.