# K983851: Capella Cochlear Emissions Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Madsen Electronics, Inc.
- Decided: Jan 28, 1999 after 90 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- 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
Capella is d¢signed to test cochlear function of both infants and adults in a hospital, nursery, ENT clinic or audiology office. It allows the operator to get information about a person's hearing without a subjective response from the individual being tested.

Source page: https://510kreport.com/device/K983851
Methodology: https://510kreport.com/methodology