Identifiers
- 510(k) Number
- K240312 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 CentralStation Wide is a patient monitoring system that integrates hemodynamic vitals with data from connected patient monitors. It allows clinicians to generate various reports in electronic PDF format, including trend, waves strip, patient status, shift, and event reports. The system also supports the export of non-diagnostic ECG waveforms for up to 24 hours, including 12-lead, to third-party systems for permanent storage and further analysis.
The device is supplied by Draeger Medical Systems, Inc. and has received FDA 510(k) clearance with the product code MHX. It is designed for use in cardiovascular settings and is classified as a Class II device. The system enables viewing of comprehensive real-time and retrospective clinical data to support effective care decisions, uniting hemodynamic vital signs with values from connected monitors.
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® CentralStation Wide | Draeger, Infinity CentralStation Wide | Draeger, PDF Infinity® CentralStation Wide Patient Monitoring Solution, PDF Infinity® CentralStation Wide Patient Monitoring Solutio
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240312 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K240312 24 fields · synced Oct 6, 2026