# K973320: Articulate Fitting System

- Pathway: 510(k) (Traditional)
- Applicant: Decibel Instruments, Inc.
- Decided: Nov 25, 1997 after 83 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 K940999 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940999: Prodigit 2000, Calmed Technology, Inc. (1994) Summary page 1.
- K945199: RH2000 Real Ear Measurement System, Madsen Electronics, Inc. (1995) Summary page 1.

## Indications for use
The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Source page: https://510kreport.com/device/K973320
Methodology: https://510kreport.com/methodology