# K013470: Modification to M2376A Devicelink System

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Nov 14, 2001 after 27 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Source page: https://510kreport.com/device/K013470
Methodology: https://510kreport.com/methodology