FDA 510(k)

Transcranial Doppler Ultrasound System

Número K: K213009 · 2022-07-08

RequerenteShenzhen Delica Medical Equipment Co., Ltd.

Data da decisão2022-07-08

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transcranial Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K213009. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Transcranial Doppler Ultrasound System?

Transcranial Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. The 510(k) number is K213009.

When did Transcranial Doppler Ultrasound System receive FDA 510(k) clearance?

Transcranial Doppler Ultrasound System received FDA 510(k) clearance on 2022-07-08, under 510(k) number K213009.

Who is the listed applicant for Transcranial Doppler Ultrasound System?

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

What is the FDA product code for Transcranial Doppler Ultrasound System?

The FDA product code for Transcranial Doppler Ultrasound System is IYN.

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

Outros registros que listam Shenzhen Delica Medical Equipment Co., Ltd. como candidato(a)

K190228Transcranial Doppler Ultrasound System K173801Transcranial Doppler Ultrasound System

Dispositivos Relacionados (Código: IYN)

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.