# K973355: Advantage 3000

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Medical Division of Cme Telemetrix
- Decided: Dec 5, 1997 after 88 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885246 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885246: Advantage, Clark Davis Medical Systems, Inc. (1989) Summary page 2.

## Indications for use
The Advantage 3000 is a Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System designed for the monitoring and analysis of electromyography data. A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients.

Source page: https://510kreport.com/device/K973355
Methodology: https://510kreport.com/methodology