FDA 510(k)

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

N.º K: K230604 · 2023-11-22

SolicitantePhilips Medizin Systeme Boeblingen GmbH

Fecha de decisión2023-11-22

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) 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 2023-11-22 under 510(k) number K230604. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K230604.

When did IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) receive FDA 510(k) clearance?

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) received FDA 510(k) clearance on 2023-11-22, under 510(k) number K230604.

Who is the listed applicant for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

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 IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)?

The FDA product code for IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) is MHX.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Philips Medizin Systeme Boeblingen GmbH como solicitante

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)K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4

Ver todos los 20 dispositivos →

Dispositivos relacionados (Código: MHX)

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.