FDA 510(k)

Philips IntelliVue GuardianSoftware (Rev. E.0X)

Número K: K212208 · 2021-09-30

RequerentePhilips Medizin Systeme Boeblingen GmbH

Data da decisão2021-09-30

Código do produtoDXJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips IntelliVue GuardianSoftware (Rev. E.0X) 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 2021-09-30 under 510(k) number K212208. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips IntelliVue GuardianSoftware (Rev. E.0X)?

Philips IntelliVue GuardianSoftware (Rev. E.0X) is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K212208.

When did Philips IntelliVue GuardianSoftware (Rev. E.0X) receive FDA 510(k) clearance?

Philips IntelliVue GuardianSoftware (Rev. E.0X) received FDA 510(k) clearance on 2021-09-30, under 510(k) number K212208.

Who is the listed applicant for Philips IntelliVue GuardianSoftware (Rev. E.0X)?

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 GuardianSoftware (Rev. E.0X)?

The FDA product code for Philips IntelliVue GuardianSoftware (Rev. E.0X) is DXJ.

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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: DXJ)

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH K173381Nexxis ORBarco N.V.K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.

Fonte oficial

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