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Carescape Monitor B650

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K102239

by GE Healthcare Finland Oy

Identifiers

510(k) Number
K102239 FDA 510(k)
FDA Product Code
MHX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Carescape Monitor B650 is a physiological patient monitor designed for continuous, non-invasive monitoring of vital signs. It detects and alarms for arrhythmias, providing real-time assessment of cardiac function and other critical parameters in clinical settings.

This device is intended for use in hospital environments, including intensive care units and general wards, where continuous patient monitoring is required. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDD regulatory standards. The monitor is classified as a Class II device and supports various configurations for patient-specific applications, though no specific sterility or MRI safety information is provided in the data.

Frequently asked questions

What clinical settings is the Carescape Monitor B650 designed for and what specific monitoring capabilities does it offer?

The Carescape Monitor B650 is specifically designed for use in hospital environments, including intensive care units (ICUs) and general wards, where continuous patient monitoring is essential. It provides non-invasive monitoring of vital signs and includes arrhythmia detection and alarms for real-time assessment of cardiac function, ensuring timely intervention for critical changes in a patient’s condition.

Is the Carescape Monitor B650 a single-use or reusable device, and what does this mean for maintenance and cleaning?

The Carescape Monitor B650 is a reusable medical device, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This design allows healthcare facilities to optimize resource use while adhering to infection control protocols to ensure safe and reliable operation.

What regulatory pathways has the Carescape Monitor B650 followed, and how does this affect its use in clinical settings?

The Carescape Monitor B650 has undergone regulatory review through the FDA 510(k) pathway and complies with the Medical Device Directive (MDD) in Europe. It is classified as a Class II device, which means it has undergone substantial equivalence determinations and adheres to stringent safety and performance standards, ensuring its suitability for use in critical care environments like ICUs and general wards.

Does the Carescape Monitor B650 come with multiple configurations or models, and how might this benefit clinical workflows?

While the data does not specify exact configurations or model variations, the Carescape Monitor B650 supports various configurations tailored for patient-specific applications. This flexibility allows clinicians to adapt the monitor to different patient needs, improving versatility in monitoring complex cases and optimizing workflow efficiency in diverse clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Healthcare Finland Oy

Sources (2)

  • FDA 510(k) K102239 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026