OtoNova/OtoNova Pro
FDA 510(k) K234095 · Otodynamics
510(k) numberK234095
Submission
- Device name
- OtoNova/OtoNova Pro
- Applicant
- Otodynamics
Hatfield, Hertfordshire, GB - Received
- December 26, 2023
- Decision date
- June 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240430 | Otoport ProEWO · Special | Otodynamics, Ltd. | 03/15/2024SE |
| K231545 | hearOAEEWO · Traditional | Hearx SA (Pty) , Ltd. | 10/27/2023SE |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional | Path Medical GmbH | 06/22/2022SE |
| K191372 | LyraEWO · Traditional | Interacoustics A/S | 07/15/2019SE |
| K180287 | GSI CortiEWO · Traditional | Grason-Stadler, Inc. | 05/11/2018SE |
| K173567 | SeraEWO · Traditional | Interacoustics A/S | 02/14/2018SE |
| K172403 | GSI NovusEWO · Traditional | Grason-Stadler, Inc. | 10/20/2017SE |
| K171506 | EasyscreenEWO · Traditional | Maico Diagnostics GmbH | 08/29/2017SE |
| K151025 | iHearTestEWO · Traditional | Ihear Medical, Inc. | 12/29/2015SE |
| K150491 | ER36 Series OAE Test SystemEWO · Special | Etymotic Research, Inc. | 03/26/2015SE |
More from Etymotic Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240430 | Otoport ProEWO · Special | 03/15/2024SE |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…EWO · Traditional | 02/23/2015SE |
| K072033 | Otodynamics OtoportEWO · Traditional | 11/13/2007SE |
| K983352 | ILO2088 Enchocheck or ILO2088 OtocheckEWO · Traditional | 12/11/1998SE |
| K983351 | ILO292 DP Echoport Plus Oae SystemEWO · Traditional | 12/11/1998SE |
| K983350 | ILO292 DP Echoport Plus Oae SystemEWO · Traditional | 12/11/1998SE |
| K962995 | ILO88. Otodynamic Analyser, Kit System for PCEWO · Traditional | 01/10/1997SE |
Questions and answers
When was OtoNova/OtoNova Pro cleared by the FDA?
OtoNova/OtoNova Pro (K234095) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 178 days after the submission was received.
What is the product code of K234095?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.