đź“‹ FDA Reference
Newport Communicat Protocol Interface Adaptor
Newport Medical Instruments
Summary: The Newport Communicat Protocol Interface Adaptor is a medical device used to facilitate communication between different medical equipment. It is primarily utilized by healthcare professionals in settings where device interoperability is crucial.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940739 ↗
Decision Date ?
March 7, 1995
Product Code ?
MOD
Device Class ?
Class 2
Evidence ?
0 studies
The Newport Communicat Protocol Interface Adaptor was cleared through the FDA 510(k) pathway on March 7, 1995. Manufactured by Newport Medical Instruments, it is classified as a Class 2 device under product code MOD.
What It Is
The Newport Communicat Protocol Interface Adaptor is designed to enable communication between various medical devices, ensuring seamless data exchange. This interface adaptor plays a critical role in integrating equipment within a healthcare setting, allowing for efficient monitoring and management of patient data. Its functionality is essential in environments where multiple devices need to work in concert, such as intensive care units.
FDA-Cleared Indications
- Facilitate communication between compatible medical devices.
- Support data exchange between medical equipment using compatible communication protocols.
Clinical Applications
- Connecting compatible medical devices within a hospital information or monitoring system.
- Supporting interoperability between equipment used for patient monitoring.
- Integrating compatible equipment in intensive care settings.
- Integrating compatible equipment in operating-room settings.
Practical Considerations
- Confirm that the adaptor is compatible with the connected devices, communication protocols, connectors and software versions before use.
- Follow the manufacturer’s installation, configuration, cleaning and maintenance instructions.
- Verify that transmitted data are accurate and complete; an interface adaptor should not be assumed to provide independent patient monitoring or clinical decision-making.
- The available FDA record does not establish MRI safety, MRI conditional status or MRI compatibility. Consult the device labeling and facility MRI-safety process before bringing it into an MRI environment.
- The available record does not specify device sizes, service life or replacement intervals. Use the manufacturer’s technical documentation for those details.
Frequently Asked Questions
What is the Newport Communicat Protocol Interface Adaptor used for?
It is used to enable communication between different medical devices, ensuring seamless data exchange and device interoperability.
What specialties typically use this device?
Specialties such as critical care, anesthesiology, and any department requiring integrated device systems frequently use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating communication between medical devices, supporting interoperability in patient care settings.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.