← Product Code [ETW](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW) · K854535

# INSERTION GAIN OPTIMIZER IGO-1000 (K854535)

_Madsen Electronics (Canada) , Ltd. · ETW · Feb 20, 1986 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K854535

## Device Facts

- **Applicant:** Madsen Electronics (Canada) , Ltd.
- **Product Code:** [ETW](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW.md)
- **Decision Date:** Feb 20, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3310
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K854535](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETW/K854535)

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