EWO — Audiometer Class II
FDA Device Classification
Classification Details
- Product Code
- EWO
- Device Class
- Class II
- Regulation Number
- 874.1050
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K234095 | otodynamics | OtoNova/OtoNova Pro | June 21, 2024 |
| K240430 | otodynamics | Otoport Pro | March 15, 2024 |
| K231545 | hearx sa (pty) | hearOAE | October 27, 2023 |
| K213345 | path medical | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na | June 22, 2022 |
| K191372 | interacoustics | Lyra | July 15, 2019 |
| K180287 | grason-stadler | GSI Corti | May 11, 2018 |
| K173567 | interacoustics | Sera | February 14, 2018 |
| K172403 | grason-stadler | GSI Novus | October 20, 2017 |
| K171506 | maico diagnostics | Easyscreen | August 29, 2017 |
| K151025 | ihear medical | iHearTest | December 29, 2015 |
| K150491 | etymotic research | ER36 Series OAE Test System | March 26, 2015 |
| K141524 | teleemg, llc usa | NEURO-AUDIO | March 12, 2015 |
| K143395 | otodynamics | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otoche | February 23, 2015 |
| K133012 | path medical | SENTIERO | June 9, 2014 |
| K130795 | interacoustics | TITAN | June 20, 2013 |
| K123624 | mimosa acoustics | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | March 28, 2013 |
| K122496 | bio-logic systems | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | November 1, 2012 |
| K121512 | bio-logic systems | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | July 26, 2012 |
| K112992 | earlogic corporation | EARLOGIC OAE TESTER | April 20, 2012 |
| K112247 | natus medical incorporated | A BAER WITH ABAER I/O FUNCTION | April 2, 2012 |