FDA 510(k)

Central Station

Número K: K242750 · 2025-06-05

RequerenteNihon Kohden Digital Health Solutions, LLC

Data da decisão2025-06-05

Código do produtoMSX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Central Station is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Digital Health Solutions, LLC. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K242750. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Central Station?

Central Station is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Nihon Kohden Digital Health Solutions, LLC. The 510(k) number is K242750.

When did Central Station receive FDA 510(k) clearance?

Central Station received FDA 510(k) clearance on 2025-06-05, under 510(k) number K242750.

Who is the listed applicant for Central Station?

The FDA 510(k) record lists Nihon Kohden Digital Health Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Central Station?

The FDA product code for Central Station is MSX.

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: MSX)

K261287Digistat CareAscom Ums Srl Unipersonale K260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH K243270TigerConnect Alarm ManagementTigerconnect K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics 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.