Infinity CentralStation Wide, Infinity M300, Infinity M300+

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231477

Identifiers

510(k) Number: K231477 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, Infinity M300, and Infinity M300+ are physiological patient monitors with arrhythmia detection and alarms, designed for continuous telemetry surveillance. These devices monitor and display vital signs, waveforms, and patient status in real time, supporting clinical decision-making in cardiovascular care settings.

These systems operate using a hospital’s existing Wi-Fi network, enabling patient mobility while maintaining continuous monitoring. Supplied as reusable medical devices, they are intended for use in clinical environments such as hospitals and cardiac care units. Authorized under FDA 510K and MDR, they comply with regulatory standards for Class II medical devices (regulation number 870.1025) and are classified under product code MHX.

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 M300+ - Dräger, Infinity® CentralStation Wide | Draeger, Dräger Infinity CentralStation, Telemetry System, M300 ... - manualzz, Dräger Infinity Central Station Quick Reference Manual, DRÄGER INFINITY M300 SERIES SUPPLEMENTAL MANUAL Pdf Download

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K231477	Class II	Active

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Manufacturer

Manufacturer: Draeger Medical Systems, Inc.

Sources (2)

FDA 510(k) K231477 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced Jun 18, 2026