FDA 510(k)

Med-link Disposable ECG Cable and Leadwires

Número K: K220447 · 2022-06-28

RequerenteShenzhen Med-Link Electronics Tech Co., Ltd.

Data da decisão2022-06-28

Código do produtoDSA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Med-link Disposable ECG Cable and Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K220447. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Med-link Disposable ECG Cable and Leadwires?

Med-link Disposable ECG Cable and Leadwires is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K220447.

When did Med-link Disposable ECG Cable and Leadwires receive FDA 510(k) clearance?

Med-link Disposable ECG Cable and Leadwires received FDA 510(k) clearance on 2022-06-28, under 510(k) number K220447.

Who is the listed applicant for Med-link Disposable ECG Cable and Leadwires?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Disposable ECG Cable and Leadwires?

The FDA product code for Med-link Disposable ECG Cable and Leadwires is DSA.

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 Med-Link Electronics Tech Co., Ltd. como candidato(a)

K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)K220448Disposable Non-invasive EEG Sensor K212752Med-link Pulse Oximeter K210441Incontinence Probe K202743Med-Link Temp-pulse Oxímetro K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: DSA)

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.