FDA 510(k)

CorSens

Número K: K160656 · 2016-11-21

Data da decisão2016-11-21

Código do produtoDXR

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CorSens is the device name listed in this FDA 510(k) record. The listed applicant is Corsens Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K160656. The device is classified under product code DXR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CorSens?

CorSens is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Corsens Medical , Ltd.. The 510(k) number is K160656.

When did CorSens receive FDA 510(k) clearance?

CorSens received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160656.

Who is the listed applicant for CorSens?

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

What is the FDA product code for CorSens?

The FDA product code for CorSens is DXR.

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: DXR)

K243566CardioTag™Cardiosense, Inc.

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.