IntelliVue Measurement Rack 6000 (867317)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253654 FDA 510(k)
- FDA Product Code
- MSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IntelliVue Measurement Rack 6000 (867317) is a Network and Communication, Physiological Monitor System designed to support the integration and organization of multiple physiological monitoring devices. It serves as a centralized platform for connecting and managing various patient monitoring sensors and devices, facilitating data acquisition, processing, and communication within clinical environments.
This device is intended for use in hospital or clinical settings, providing a structured framework for monitoring systems such as ECG, blood pressure, pulse oximetry, and other physiological parameters. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDR regulatory standards and is classified as a Class II medical device under the Medical Specialty of Cardiovascular. The rack is designed for integration with compatible IntelliVue monitoring systems and supports standardized communication protocols for seamless data flow.
Frequently asked questions
What clinical environments is the IntelliVue Measurement Rack 6000 intended for use in?
The IntelliVue Measurement Rack 6000 is specifically designed for hospital or clinical settings where centralized monitoring of physiological parameters is required. It serves as a structured platform to integrate and manage multiple monitoring devices, such as ECG, blood pressure, and pulse oximetry systems, ensuring seamless data acquisition and communication within these environments.
Is the IntelliVue Measurement Rack 6000 a single-use or reusable device?
The IntelliVue Measurement Rack 6000 is supplied as a reusable medical device. This means it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance procedures, rather than being discarded after a single use.
What types of monitoring systems can be integrated with the IntelliVue Measurement Rack 6000?
The IntelliVue Measurement Rack 6000 is designed for integration with compatible IntelliVue monitoring systems and supports various physiological parameters such as ECG, blood pressure, and pulse oximetry. It facilitates standardized communication protocols to ensure seamless data flow between these systems and other connected devices.
How is the regulatory status of the IntelliVue Measurement Rack 6000 determined?
The IntelliVue Measurement Rack 6000 is classified as a Class II medical device under the Cardiovascular specialty and adheres to both FDA 510(k) and MDR (Medical Device Regulation) standards. It was determined to be substantially equivalent through a traditional 510(k) review process by the FDA’s Cardiovascular Advisory Committee, with a decision date of March 30, 2026.
What communication protocols does the IntelliVue Measurement Rack 6000 support for data integration?
While the exact protocols are not detailed in the provided data, the IntelliVue Measurement Rack 6000 is explicitly designed to support standardized communication protocols for seamless data acquisition and integration with compatible IntelliVue monitoring systems. This ensures compatibility with a wide range of physiological sensors and devices, enabling centralized monitoring and management.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253654 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
Sources (2)
- FDA 510(k) K253654 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026