# K143670: Ics Chartr EP 200 with Vemp

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics A/S
- Decided: Oct 23, 2015 after 303 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
Longest line of descent: 4 generations back to K002985 (2000). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092373: Ics Chartr EP 200, Gn Otometrics (2009) Summary page 4.

## Most influential descendants
- K163326: SmartEP (2017), 1 descendant of its own
- K162037: Eclipse with VEMP (2017), 1 descendant of its own
- K242954: Integrity V500 (Integrity, Integrity with VEMP) (2024), 0 descendants of its own
- K193033: GSI Audera Pro (2020), 0 descendants of its own

## Indications for use
The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

Source page: https://510kreport.com/device/K143670
Methodology: https://510kreport.com/methodology