FDA 510(k)

Monitor B125, Monitor B105

N.º K: K171580 · 2017-11-01

SolicitanteGe Medical Systems (China) Co., Ltd.

Fecha de decisión2017-11-01

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Monitor B125, Monitor B105 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems (China) Co., Ltd.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K171580. 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 B125, Monitor B105?

Monitor B125, Monitor B105 is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Ge Medical Systems (China) Co., Ltd.. The 510(k) number is K171580.

When did Monitor B125, Monitor B105 receive FDA 510(k) clearance?

Monitor B125, Monitor B105 received FDA 510(k) clearance on 2017-11-01, under 510(k) number K171580.

Who is the listed applicant for Monitor B125, Monitor B105?

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

What is the FDA product code for Monitor B125, Monitor B105?

The FDA product code for Monitor B125, Monitor B105 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

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.