FDA 510(k)

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

Número K: K243216 · 2024-12-10

Data da decisão2024-12-10

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is the device name listed in this FDA 510(k) record. The listed applicant is Analog Devices. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K243216. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is a medical device that received FDA 510(k) clearance on 2024-12-10. The listed applicant is Analog Devices. The 510(k) number is K243216.

When did Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) receive FDA 510(k) clearance?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) received FDA 510(k) clearance on 2024-12-10, under 510(k) number K243216.

Who is the listed applicant for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

The FDA 510(k) record lists Analog Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

The FDA product code for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is MWI.

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: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.