FDA 510(k)

UniPulse

Número K: K182905 · 2018-12-14

Data da decisão2018-12-14

Código do produtoDRL

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

UniPulse is the device name listed in this FDA 510(k) record. The listed applicant is Seaward Group. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182905. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UniPulse?

UniPulse is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Seaward Group. The 510(k) number is K182905.

When did UniPulse receive FDA 510(k) clearance?

UniPulse received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182905.

Who is the listed applicant for UniPulse?

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

What is the FDA product code for UniPulse?

The FDA product code for UniPulse is DRL.

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: DRL)

K190437Delta 3300Netech Corporation

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.