Identifiers
- 510(k) Number
- K083861 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 Titan Imp440 Module is an electroacoustic impedance test instrument designed for tympanometry and acoustic reflex measurement. It is part of the Titan Platform, a modular system that integrates with PC software for data management and patient testing.
The device is supplied as a handheld form factor with optional accessories, including a cradle and shoulder box. It operates via a PC interface and is intended for single-use in clinical settings. The Titan Imp440 Module is regulated under FDA 510(k) clearance.
Frequently asked questions
What is the Titan Imp440 Module used for?
The Titan Imp440 Module is an electroacoustic impedance test instrument designed for measuring tympanometry and acoustic reflexes. It is part of the Titan Platform, a modular system that integrates with PC software for data management and patient testing.
How is the device supplied?
The device is supplied as a handheld form factor with optional accessories, including a cradle and shoulder box. It operates via a PC interface.
Is the Titan Imp440 Module intended for single use?
Yes, the device is intended for single-use in clinical settings.
What is the regulatory status of the Titan Imp440 Module?
The Titan Imp440 Module is regulated under FDA 510(k) clearance.
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: Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan Imp440 ..., PDF Titan - interacoustics.com, Titan | Handheld tympanometer | Interacoustics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083861 | Class II | Active |
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Manufacturer
- Manufacturer
- Interacoustics AS
Sources (1)
- FDA 510(k) K083861 24 fields · synced Sep 25, 2026