# K991853: Interacoustics EP 15 Abr Stand Alone Unit

- Pathway: 510(k) (Traditional)
- Applicant: Idem (Int'L Dist. of Electronics For Medicine)
- Decided: Oct 25, 1999 after 146 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- 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 its predicate without a number.
- (no number) ICS Medical Corp. Chartr EP System: named in the summary without a submission number

## Indications for use
The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computer-based testing. Data is collected in a Windows 98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Source page: https://510kreport.com/device/K991853
Methodology: https://510kreport.com/methodology