Madsen IGO1500 Insertion Gain Optimizer
by Madsen Electronics (Canada), Ltd.
510(k) K884372
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884372 | Date13 Feb 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ETW
- FDA applicant
- Madsen Electronics (Canada) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3310
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Madsen IGO 1500 Insertion Gain Optimizer is a Hearing Aid/Earphone and Analysis System designed to measure and optimize insertion gain in hearing aids. It falls under the nomenclature for calibrators used in audiological assessments, ensuring accurate fitting and performance evaluation of hearing devices.
This device is intended for use in clinical settings by audiologists or ENT specialists, providing precise measurements to enhance hearing aid fitting protocols. Supplied as a reusable instrument, it adheres to FDA 510(k) clearance (K884372) under the Traditional pathway, classified as a Class 2 medical device (ETW product code). No sterility or single-use specifications are noted in the regulatory data.