Infinity Delta and Kappa Series Monitors with VF6 Modifications
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060039 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 Infinity Delta and Kappa Series Monitors with VF6 Modifications are physiological patient monitors designed for real-time multi-parameter monitoring. These devices integrate inputs such as ECG, respiratory gases (CO₂, N₂O, O₂, and anesthetic agents), and other physiological signals via modular pods to provide continuous patient data and derived gas information. They are classified as Class II devices and include arrhythmia detection and alarm functionalities.
These monitors are intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. Supplied as reusable devices, they undergo regulatory review under FDA 510(k) clearance (K060039) and are classified under the Medical Specialty of Cardiovascular. The devices are not single-use and require proper maintenance and calibration as per manufacturer guidelines. No specific MRI safety information is provided in the data.
Frequently asked questions
What clinical settings are the Infinity Delta and Kappa Series Monitors with VF6 Modifications designed for?
These monitors are specifically designed for use in high-acuity environments such as operating rooms, intensive care units, and emergency departments. Their multi-parameter capabilities—including ECG, respiratory gas analysis (CO₂, N₂O, O₂, and anesthetic agents), and arrhythmia detection—make them ideal for continuous patient monitoring where real-time data is critical to clinical decision-making.
Are the Infinity Delta and Kappa Series Monitors with VF6 Modifications single-use or reusable?
These monitors are not single-use devices. They are reusable and require regular maintenance and calibration as outlined in the manufacturer’s guidelines to ensure accurate and reliable performance over time. Proper upkeep is essential for sustaining their functionality in clinical settings.
What types of physiological signals can the Infinity Delta and Kappa Series Monitors with VF6 Modifications process?
The monitors integrate multiple physiological inputs via modular pods, including ECG signals and respiratory gases (such as CO₂, N₂O, O₂, and anesthetic agents). They also provide derived gas information and include arrhythmia detection and alarm functionalities to enhance patient safety during monitoring.
How are these monitors regulated and approved for use?
The Infinity Delta and Kappa Series Monitors with VF6 Modifications are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance (K060039). This clearance confirms their substantial equivalence to a predicate device, ensuring they meet regulatory standards for safety and effectiveness in their intended clinical applications.
Do these monitors include any specific safety features for MRI environments?
The provided data does not include any information regarding MRI safety for the Infinity Delta and Kappa Series Monitors with VF6 Modifications. Clinicians should verify compatibility with their facility’s MRI protocols before use in such environments.
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: Infinity Delta and Kappa Series Monitors With Vf6 Modifications ..., Infinity Delta And Kappa Series Monitors With Vf6 Modifications 510 (k ..., PDF K060039 Infinity Delta and Kappa Series Monitors With Vf6 Modifications, PDF fiagermedical to - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060039 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K060039 24 fields · synced Oct 6, 2026