INSERTION GAIN OPTIMIZER IGO-1000
Device Facts
| Record ID | K854535 |
|---|---|
| Device Name | INSERTION GAIN OPTIMIZER IGO-1000 |
| Applicant | Madsen Electronics (Canada) , Ltd. |
| Product Code | ETW · Ear, Nose, Throat |
| Decision Date | Feb 20, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3310 |
| Device Class | Class 2 |
Regulatory Classification
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.
