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VitaLogik Model 4000/4500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073140

by Mennen Medical , Ltd.

Identifiers

510(k) Number
K073140 FDA 510(k)
FDA Product Code
DSI 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 VitaLogik Model 4000/4500 is a multi-parameter patient monitor classified as a Detector and Alarm, Arrhythmia, designed to continuously monitor and alert for cardiac arrhythmias. It provides real-time display and analysis of vital signs including electrocardiogram (ECG), respiration, non-invasive blood pressure (NIBP), oxygen saturation (SpO₂), and temperature. Optional add-ons extend functionality to include capnography (EtCO₂) and anesthetic gas monitoring, enhancing its utility in critical care environments.

This device is intended for use in clinical settings such as intensive care units, operating rooms, and emergency departments. Supplied as a reusable medical device, it requires proper sterilization and maintenance per manufacturer guidelines. The monitor operates in non-MRI environments and is available in two configurations: a non-invasive Model 4000 and an invasive Model 4500. Regulatory clearance under FDA 510K (K073140) and compliance with 21 CFR 870.1025 ensure its safety and performance standards. Storage and handling must adhere to manufacturer instructions to preserve functionality.

Frequently asked questions

What clinical settings is the VitaLogik 4000/4500 designed for?

The VitaLogik 4000/4500 is specifically engineered for high-acuity environments where real-time cardiac monitoring is critical. This includes intensive care units (ICUs), operating rooms (ORs), and emergency departments (EDs), where continuous assessment of arrhythmias and vital signs is essential for patient safety and clinical decision-making.

How is the VitaLogik 4000/4500 supplied and what does this mean for its use?

The VitaLogik 4000/4500 is supplied as a reusable medical device. This means it is intended for repeated use across multiple patients, provided it undergoes proper sterilization and maintenance as outlined by the manufacturer’s guidelines. Reusability ensures cost-effectiveness and reduces waste, but it also requires adherence to strict cleaning and disinfection protocols to prevent cross-contamination.

What distinguishes the Model 4000 from the Model 4500?

The primary distinction lies in their invasiveness: the Model 4000 is designed for non-invasive monitoring, while the Model 4500 supports invasive procedures. The Model 4500 may include additional features or compatibility for invasive monitoring techniques (e.g., arterial line connections), though the core functionality—such as ECG, NIBP, SpO₂, and temperature—remains consistent across both models.

Does the VitaLogik 4000/4500 require special handling or storage conditions?

Yes, proper storage and handling are critical to preserve functionality. The device must be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. Manufacturer instructions should be followed to ensure calibration accuracy, sensor integrity, and longevity. Avoid exposure to moisture or contaminants, as these can compromise performance or require additional cleaning cycles.

Can the VitaLogik 4000/4500 be used in an MRI environment?

No, the VitaLogik 4000/4500 is explicitly designed for non-MRI environments. Magnetic resonance imaging (MRI) generates strong magnetic fields and radiofrequency waves that can interfere with electronic medical devices, potentially causing malfunctions or safety hazards. Always verify the device’s placement relative to MRI machines to prevent exposure.

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: VITALOGIK 4000 and 4500 User Manual Rev G Nov 2014, Mennen Medical VitaLogik 4000 4000, VitaLogik 4500 4500 ... - Manualzz, User Manual: Vitalogik 4000 / 6000 Series® | PDF - Scribd, Mennen Medical - VitaLogik 4000 Series - MedWrench

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mennen Medical , Ltd.

Sources (1)

  • FDA 510(k) K073140 24 fields · synced Oct 5, 2026