FDA 510(k)

Physiotrace

Número K: K171244 · 2017-08-23

Data da decisão2017-08-23

Código do produtoDRX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Physiotrace is the device name listed in this FDA 510(k) record. The listed applicant is Nimbleheart, Inc.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) number K171244. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Physiotrace?

Physiotrace is a medical device that received FDA 510(k) clearance on 2017-08-23. The listed applicant is Nimbleheart, Inc.. The 510(k) number is K171244.

When did Physiotrace receive FDA 510(k) clearance?

Physiotrace received FDA 510(k) clearance on 2017-08-23, under 510(k) number K171244.

Who is the listed applicant for Physiotrace?

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

What is the FDA product code for Physiotrace?

The FDA product code for Physiotrace is DRX.

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.