FDA 510(k)

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

N.º K: K231870 · 2023-12-13

SolicitanteGe Medical Systems Information Technologies, Inc.

Fecha de decisión2023-12-13

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing 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 2023-12-13 under 510(k) number K231870. 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 CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K231870.

When did CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System receive FDA 510(k) clearance?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231870.

Who is the listed applicant for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing 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 CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

The FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing 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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