# K994430: Impact.WF Mobile Waveform Receiving System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Mar 28, 2000 after 90 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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
Longest line of descent: 2 generations back to K962827 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971868: Impact (Informing Mobile Personnel and Care Tracking) Pager System, Marquette Electronics, Inc. (1997) Summary page 1.

## Indications for use
The IMPACT.wf Mobile Waveform Receiving System is intended for the secondary annunciation and display of selected alarm conditions at remote locations throughout a defined area of coverage. The device is intended for use within the hospital/facility environment. The intended patient population is the same as the device generating the information used by the IMPACT.wf. The IMPACT.wf is not intended to replace primary monitoring via the central station, telemetry system, or patient bedside monitor.

Source page: https://510kreport.com/device/K994430
Methodology: https://510kreport.com/methodology