# K970324: Gsi SA60 Dpoae System

- Pathway: 510(k) (Traditional)
- Applicant: Grason-Stadler, Inc.
- Decided: Jun 6, 1997 after 130 days
- Product code: ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems)
- Device class: 2
- Regulation: 21 CFR 874.3310
- 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 K934658 (1994). 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)
- K934658: Gsi 60 Dpoae System, Lucas Grason-Stadler, Inc. (1994) Summary page 1.

## Indications for use
The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the stdtus of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GS! 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.

Source page: https://510kreport.com/device/K970324
Methodology: https://510kreport.com/methodology