EWO — Audiometer Class II
FDA product code EWO covers "Audiometer", a Class II medical device regulated under 21 CFR 874.1050. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |