Otowave 202 Portable Tympanometer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150163 FDA 510(k)
- FDA Product Code
- NAS 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 Otowave 202 Portable Tympanometer is a diagnostic device used to evaluate the function of the eardrum and middle ear system. It supports middle ear testing across all age groups to assist clinicians in assessing patient hearing health.
This handheld device is designed for use in clinical settings to facilitate point-of-care assessments. It is regulated under FDA 510K clearance as a Class 2 medical device.
Frequently asked questions
What is the Otowave 202 Portable Tympanometer used for?
The Otowave 202 is a diagnostic device designed to evaluate the function of the eardrum and middle ear system. It supports middle ear testing across all age groups to assist clinicians in assessing patient hearing health in clinical settings.
How is the Otowave 202 Portable Tympanometer supplied?
The device is supplied as a handheld unit designed for point-of-care assessments in clinical settings. It is manufactured by Amplivox, Ltd. and comes with FDA 510K clearance as a Class 2 medical device.
What are the regulatory approvals for the Otowave 202?
The Otowave 202 Portable Tympanometer is regulated under FDA 510K clearance as a Class 2 medical device. It has a K-number K150163 and was reviewed by the Ear, Nose, Throat advisory committee.
Can the Otowave 202 be used for all age groups?
Yes, the Otowave 202 Portable Tympanometer supports middle ear testing across all age groups, making it suitable for pediatric and adult patients in clinical settings.
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: Otowave 202 | Handheld diagnostic tympanometer | Amplivox, AMPLIVOX OTOWAVE 202 OPERATING MANUAL Pdf Download, Handheld and desktop tympanometers - Amplivox, Handheld Diagnostic Tympanometer- Otowave 202 & 202H | MEDRX
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150163 | Class II | Active |
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Manufacturer
- Manufacturer
- Amplivox, Ltd.
Sources (1)
- FDA 510(k) K150163 24 fields · synced Sep 22, 2026