FDA 510(k)

Localizador Apex (AL-Pex), Localizador Apex (AL-Pex+)

Número K: K232717 · 2023-12-22

RequerenteChangzhou Haili Medical Co., Ltd.

Data da decisão2023-12-22

Código do produtoLQY

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Haili Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232717. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Changzhou Haili Medical Co., Ltd.. The 510(k) number is K232717.

When did Apex Locator (AL-Pex), Apex Locator (AL-Pex+) receive FDA 510(k) clearance?

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232717.

Who is the listed applicant for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

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

What is the FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

The FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is LQY.

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: LQY)

K252224Localizador Apex (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242383Localizador ApexShenzhen Rogin Medical Co., Ltd.K242765Electronic Apex Locator (Alpha Apex I)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Localizador ApexCefla S.C.K212178Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd.K210789EQ-PEXMeta Systems Co., Ltd.

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.