FDA 510(k)

MUSE Cardiology Information System

N.º K: K152993 · 2016-01-12

SolicitanteGe Medical Systems Information Technologies, Inc.

Fecha de decisión2016-01-12

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

MUSE Cardiology Information System 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 2016-01-12 under 510(k) number K152993. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MUSE Cardiology Information System?

MUSE Cardiology Information System is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K152993.

When did MUSE Cardiology Information System receive FDA 510(k) clearance?

MUSE Cardiology Information System received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152993.

Who is the listed applicant for MUSE Cardiology Information System?

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 MUSE Cardiology Information System?

The FDA product code for MUSE Cardiology Information System is DQK.

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

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P K251670MAC 7 Resting ECG Analysis System K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)K233810Portrait VSM K234130Portrait™ 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 O

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Dispositivos relacionados (Código: DQK)

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Fuente oficial

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