# K080060: Vivosonic Neuroscreen

- Pathway: 510(k) (Traditional)
- Applicant: Vivosonic, Inc.
- Decided: Apr 4, 2008 after 86 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Vivosonic NeuroScreen Tm is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen TM is indicated for newborns and infants from 34 weeks gestational age to 6 months.

Source page: https://510kreport.com/device/K080060
Methodology: https://510kreport.com/methodology