FDA 510(k)

BrainPulse 1100

Número K: K170926 · 2017-04-28

Data da decisão2017-04-28

Código do produtoPOP

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BrainPulse 1100 is the device name listed in this FDA 510(k) record. The listed applicant is Jan Medical, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170926. The device is classified under product code POP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BrainPulse 1100?

BrainPulse 1100 is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Jan Medical, Inc.. The 510(k) number is K170926.

When did BrainPulse 1100 receive FDA 510(k) clearance?

BrainPulse 1100 received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170926.

Who is the listed applicant for BrainPulse 1100?

The FDA 510(k) record lists Jan Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BrainPulse 1100?

The FDA product code for BrainPulse 1100 is POP.

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

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.