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Carescape B650

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191149

by GE Healthcare Finland Oy

Identifiers

510(k) Number
K191149 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 B650 is a physiological patient monitor designed for continuous, non-invasive monitoring of vital signs, including arrhythmia detection and alarms. As classified under the FDA’s device type ‘Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)’, it provides real-time assessment of cardiovascular parameters, ensuring clinical decision-making in acute and critical care settings.

This device is intended for use in hospital environments, including intensive care units and cardiac care units. Supplied as a reusable medical instrument, it requires adherence to standard sterilisation protocols. The Carescape B650 complies with FDA 510(k) clearance (K191149, K213181) and EU MDR authorisation, with operational specifications including a relative humidity tolerance of 10% to 90% non-condensing. Its regulatory classification is Class II, and it is manufactured by GE Healthcare Finland Oy.

Frequently asked questions

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

The Carescape B650 is specifically designed for use in hospital environments, including intensive care units (ICUs) and cardiac care units. It provides continuous, non-invasive monitoring of vital signs with a focus on cardiovascular parameters, including arrhythmia detection and alarms. This ensures real-time assessment to support clinical decision-making in acute and critical care settings.

How is the Carescape B650 supplied and what sterilization requirements apply to it?

The Carescape B650 is supplied as a reusable medical instrument. Since it is reusable, it must adhere to standard sterilization protocols to maintain safety and functionality for repeated use in clinical settings.

What environmental conditions should be considered when using the Carescape B650, particularly regarding humidity?

The Carescape B650 is designed to operate reliably within a relative humidity range of 10% to 90% non-condensing. This ensures stable performance in typical hospital environments where humidity levels can vary.

What regulatory pathways has the Carescape B650 followed, and what does this mean for its use in different markets?

The Carescape B650 has obtained FDA 510(k) clearance (with K-numbers K191149 and K213181) and EU MDR authorization, indicating compliance with both U.S. and European regulatory standards. This means it is legally marketable in the U.S. and EU for its intended use as a physiological patient monitor with arrhythmia detection and alarms, adhering to the respective regulatory requirements of each region.

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. Sources consulted: PDF CARESCAPE Monitor B650 - GE Healthcare, GE HEALTHCARE CARESCAPE Monitor B650 Technical Manual, K191149 - CARESCAPE B650 | FDA 510(k) | GE Healthcare Finland Oy, K213181 FDA 510(k) - CARESCAPE B650 | GE Healthcare Finland Oy, Download GE HEALTHCARE CARESCAPE Monitor B650 Technical Manual | ManualsLib

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Healthcare Finland Oy

Sources (2)

  • FDA 510(k) K191149 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026