GN Otometrics Insert Earphones
FDA 510(k) K081234 · Gn Otometrics
510(k) numberK081234
Submission
- Device name
- GN Otometrics Insert Earphones
- Applicant
- Gn Otometrics
Schaumburg, IL, US - Received
- May 1, 2008
- Decision date
- July 14, 2008
- 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 |
|---|---|---|---|
| K234095 | OtoNova/OtoNova ProEWO · Traditional | Otodynamics | 06/21/2024SE |
| 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 |
More from Ihear Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161707 | Madsen ZodiacETY · Special | 09/01/2016SE |
| K151504 | ICS ImpulseGWN · Traditional | 11/16/2015SE |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | 02/27/2014SE |
| K122550 | Ics ImpulseGWN · Traditional | 02/01/2013SE |
| K122028 | Aurical HitETW · Traditional | 10/23/2012SE |
| K122067 | Type 1077 AccuscreenGWJ · Traditional | 09/27/2012SE |
| K092373 | Ics Chartr Ep 200GWJ · Special | 09/03/2009SE |
Questions and answers
When was GN Otometrics Insert Earphones cleared by the FDA?
GN Otometrics Insert Earphones (K081234) received a 510(k) decision of Substantially Equivalent on July 14, 2008, 74 days after the submission was received.
What is the product code of K081234?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.