Modification To M2376A Devicelink System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013470 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The M2376A Devicelink System functions as a data gateway for clinical environments. It receives digital data from external bedside medical devices via device-specific cables, converts the data into HL7 format, and transmits the information to networked Clinical Information Systems.
This device is intended for operation by healthcare professionals. It is classified as a physiological patient monitor without arrhythmia detection or alarms and has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the M2376A Devicelink System?
The system serves as a data gateway within clinical environments. It collects digital data from external bedside medical devices through specific cables, converts that data into HL7 format, and transmits it to networked Clinical Information Systems.
Does the M2376A Devicelink System provide patient alarms?
No, the device is classified as a physiological patient monitor that does not include arrhythmia detection or alarm functions. It is designed specifically for data transmission and integration rather than active patient monitoring or alerting.
Who is authorized to operate this device?
The M2376A Devicelink System is intended for operation exclusively by healthcare professionals. This ensures that the data gateway is managed by trained staff within a clinical setting.
What is the regulatory status of this device?
The M2376A Devicelink System has received FDA 510(k) clearance. It was determined to be substantially equivalent to existing devices under the cardiovascular advisory committee.
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: K020494 FDA 510(k) - MODIFICATION TO M2376A DEVICELINK SYSTEM, MODIFICATION TO M2376A DEVICELINK SYSTEM (K020494) — FDA 510 (k ..., MODIFICATION TO M2376A DEVICELINK SYSTEM 510(k) K020494 - 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 | K013470 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems, Inc.
Sources (1)
- FDA 510(k) K013470 24 fields · synced Sep 23, 2026