# K972862: Amplaid 171S

- Pathway: 510(k) (Traditional)
- Applicant: Amplifon S.P.A.
- Decided: Oct 31, 1997 after 88 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
Longest line of descent: 1 generation back to K891988 (1989). 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)
- K891988: Amplaid A308 Clinical Audiometer, Amplus Corp. (1989) Summary page 1.

## Indications for use
The Amplaid 1718S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Source page: https://510kreport.com/device/K972862
Methodology: https://510kreport.com/methodology