FDA 510(k)

Delphi MCS Electrode Cap

Número K: K243243 · 2025-02-06

Data da decisão2025-02-06

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Delphi MCS Electrode Cap is the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neuroscience, Ltd.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K243243. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Delphi MCS Electrode Cap?

Delphi MCS Electrode Cap is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Quantalx Neuroscience, Ltd.. The 510(k) number is K243243.

When did Delphi MCS Electrode Cap receive FDA 510(k) clearance?

Delphi MCS Electrode Cap received FDA 510(k) clearance on 2025-02-06, under 510(k) number K243243.

Who is the listed applicant for Delphi MCS Electrode Cap?

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

What is the FDA product code for Delphi MCS Electrode Cap?

The FDA product code for Delphi MCS Electrode Cap is GXY.

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: GXY)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Copo MRI/CT (Modelos 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Copo MRI/CT-conjunto (Modelos 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Copo MRI/CT-mini conjunto (Modelos 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR Conditional Cup ElectrodesTechnomed Europe

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.