FDA 510(k)

Electrocardiograph, model: ECG301

Número K: K232816 · 2024-06-07

RequerenteShenzhen LE Medical Technology Co., Ltd.

Data da decisão2024-06-07

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electrocardiograph, model: ECG301 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen LE Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K232816. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Electrocardiograph, model: ECG301?

Electrocardiograph, model: ECG301 is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Shenzhen LE Medical Technology Co., Ltd.. The 510(k) number is K232816.

When did Electrocardiograph, model: ECG301 receive FDA 510(k) clearance?

Electrocardiograph, model: ECG301 received FDA 510(k) clearance on 2024-06-07, under 510(k) number K232816.

Who is the listed applicant for Electrocardiograph, model: ECG301?

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

What is the FDA product code for Electrocardiograph, model: ECG301?

The FDA product code for Electrocardiograph, model: ECG301 is DPS.

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: DPS)

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361Sistema de Análise de ECG AccurECG (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial

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.