# K983046: American Electromedics Race Car Tympanometer W/Integral Printer

- Pathway: 510(k) (Traditional)
- Applicant: American Electromedics Corp.
- Decided: Nov 17, 1998 after 77 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- 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 K955289 (1995). 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)
- K955289: Race Car Tympanometer, American Electromedics Corp. (1995) Summary page 1.

## Indications for use
The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Source page: https://510kreport.com/device/K983046
Methodology: https://510kreport.com/methodology