Identifiers
- 510(k) Number
- K151616 FDA 510(k)
- FDA Product Code
- ETY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1090 FDA 510(k)
- Regulation Number
- 874.1090 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AT235 is an automatic impedance audiometer with built-in screening audiometry. It is designed for both screening and diagnostic work in clinical settings.
This device is manufactured by Interacoustics A/S and has received FDA 510(k) clearance. It requires annual technical maintenance to ensure performance and specifications are maintained.
Frequently asked questions
What is the primary function of the AT235?
The AT235 is an automatic impedance audiometer that features built-in screening audiometry. It is specifically engineered to support both screening and diagnostic procedures within clinical environments.
Does the AT235 require any ongoing maintenance?
Yes, the device requires annual technical maintenance. This routine service is necessary to ensure that the unit continues to meet its performance standards and technical specifications over time.
What is the regulatory status of the AT235?
The AT235, manufactured by Interacoustics A/S, has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF AT235 - Interacoustics, Interacoustics AT235 Instructions For Use Manual, PDF AT235 Impedance Audiometer - Interacoustics, PDF AT235 Technical Specifications - doc.es.aau.dk
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151616 | Class II | Active |
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Manufacturer
- Manufacturer
- Interacoustics A/S
Sources (1)
- FDA 510(k) K151616 24 fields · synced Sep 27, 2026