Infinity Modular Monitors VF4 Modifications
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033694 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 Modular Monitors VF4 Modifications are physiological patient monitors designed for arrhythmia detection and alarming. Classified as a Class II device under FDA regulations, they monitor multiple parameters including ECG (with arrhythmia/ST segment analysis), pressure, temperature, cardiac output, SpO₂, EEG, and respiratory gases. These monitors are intended for use in clinical settings to provide continuous patient vital sign assessment and early detection of cardiac irregularities.
These monitors are supplied as reusable medical devices and are intended for use in hospital and clinical environments. They are not sterile and require proper cleaning and maintenance between uses. The Infinity Modular Monitors VF4 Modifications comply with FDA 510(k) clearance (K033694) and are regulated under the FDA’s medical specialties classification for cardiovascular applications. They are distributed by Draeger Medical Systems, Inc., and are designed for integration with compatible modules such as the Scio system.
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 MODULAR MONITORS VF4 MODIFICATIONS (K033694) — FDA 510(k ..., Infinity Modular Monitors Vf4 Modifications With Scio, Models Delta ..., Infinity Modular Monitors Vf4 Modifications With Scio, Models Delta ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033694 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K033694 24 fields · synced Oct 6, 2026