Identifiers
- 510(k) Number
- K945099 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)
A physiological patient monitor designed for arrhythmia detection and alarm functionality, classified as a Class II device under FDA regulations. The device is specifically engineered to monitor cardiac parameters, ensuring accurate synchronization for radiographic imaging across various modalities, including nuclear medicine, computed tomography, and magnetic resonance imaging.
Used primarily in clinical settings such as radiology and cardiology departments, the Parameters Monitors are intended for single-use or reusable applications depending on the model variant. Supplied sterile or non-sterile as specified, the device operates within MRI-safe parameters and is available in configurations tailored for different patient monitoring needs. Authorized under FDA 510(k) clearance (K945099) with product code MHX, it adheres to regulatory standards for cardiovascular monitoring devices.
Frequently asked questions
What clinical settings is the Parameters Monitors primarily designed for, and how does it integrate with imaging procedures?
The Parameters Monitors are specifically designed for clinical settings like radiology and cardiology departments. It is engineered to monitor cardiac parameters with precise synchronization for radiographic imaging across modalities such as nuclear medicine, computed tomography (CT), and magnetic resonance imaging (MRI), ensuring accurate patient monitoring during these procedures.
Are the Parameters Monitors available in both single-use and reusable configurations, and how should I determine which version to purchase?
Yes, the Parameters Monitors are available in both single-use and reusable variants depending on the model variant. To determine which version to purchase, check the product specifications or consult with Ivy Biomedical Systems, Inc., as the sterility (sterile or non-sterile) and reuse capability are explicitly tied to the model configuration.
What regulatory pathway was followed for FDA clearance of the Parameters Monitors, and what does this mean for its safety and performance?
The Parameters Monitors received FDA clearance through a Traditional 510(k) pathway, determined to be Substantially Equivalent to a predicate device. This process ensures that the device meets FDA standards for cardiovascular monitoring, including arrhythmia detection and alarm functionality, and adheres to regulatory requirements for Class II medical devices.
Does the Parameters Monitors operate safely within MRI environments, and if so, what imaging modalities does it support?
Yes, the Parameters Monitors are designed to operate within MRI-safe parameters, making them suitable for use in MRI environments. It is specifically engineered to synchronize with various imaging modalities, including nuclear medicine, computed tomography (CT), and magnetic resonance imaging (MRI), ensuring reliable cardiac monitoring during these procedures.
How do I identify the correct model of Parameters Monitors for my facility’s specific patient monitoring needs?
The Parameters Monitors come in multiple configurations tailored to different patient monitoring needs, as indicated by the extensive list of FEI numbers (e.g., 3021219789, 3013500228, etc.) in the regulatory records. To identify the correct model, verify the intended use (e.g., single-use vs. reusable, sterile vs. non-sterile) and consult Ivy Biomedical Systems, Inc. or their technical documentation, as these details are tied to specific model variants.
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: PARAMETERS MONITORES (K945099) — FDA 510 (k) | Innolitics, PARAMETERS MONITORES 510(k) K945099 - FDA.report, PDF K945099 - Parameters Monitores, Parameters Monitores - Beudamed, IVY BIOMEDICAL SYSTEMS, INC. FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945099 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K945099 24 fields · synced Sep 18, 2026