FDA 510(k)

Philips IntelliVue XDS Software

Número K: K182637 · 2019-04-26

RequerentePhilips Medizin Systeme Boeblingen GmbH

Data da decisão2019-04-26

Código do produtoMSX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips IntelliVue XDS Software is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K182637. 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 Philips IntelliVue XDS Software?

Philips IntelliVue XDS Software is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K182637.

When did Philips IntelliVue XDS Software receive FDA 510(k) clearance?

Philips IntelliVue XDS Software received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182637.

Who is the listed applicant for Philips IntelliVue XDS Software?

The FDA 510(k) record lists Philips Medizin Systeme Boeblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips IntelliVue XDS Software?

The FDA product code for Philips IntelliVue XDS Software 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

Outros registros que listam Philips Medizin Systeme Boeblingen GmbH como candidato(a)

K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550 K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

Ver todos os 20 dispositivos →

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.