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FDA 510(k)

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

N.º K: K253277 · 2026-07-24

SolicitanteGe Medical Systems Information Technologies, Inc.
Fecha de decisión2026-07-24
Código de productoMHX
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K253277. 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 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K253277.

When did Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P receive FDA 510(k) clearance?

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P recibieron la aprobación de 510(k) de la FDA el 24 de julio de 2026, bajo el número de 510(k) K253277.

Who is the listed applicant for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

The FDA product code for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is MHX.

Ensayos clínicos relacionados

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Otros registros que enlistan a Ge Medical Systems Information Technologies, Inc. como solicitante

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.

K251670MAC 7 Resting ECG Analysis SystemK242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)K233810Portrait VSMK234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OK231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

Ver todos los 21 dispositivos →

Dispositivos relacionados (Código: MHX)

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.

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 OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLC

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.

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