EP15 Software Module, EP25 Software Module
FDA 510(k) K090406 · Interacoustics AS
510(k) numberK090406
Submission
- Device name
- EP15 Software Module, EP25 Software Module
- Applicant
- Interacoustics AS
Assens, DK - Received
- February 17, 2009
- Decision date
- July 22, 2009
- 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 |
|---|---|---|
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…ETY · Traditional | 04/09/2009SE |
| K052562 | Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.EWO · Traditional | 12/23/2005SE |
| K043219 | Affinity (Cabinet Name), AC440, HIT440, or the Combination of SystemsEWO · Traditional | 02/04/2005SE |
Questions and answers
When was EP15 Software Module, EP25 Software Module cleared by the FDA?
EP15 Software Module, EP25 Software Module (K090406) received a 510(k) decision of Substantially Equivalent on July 22, 2009, 155 days after the submission was received.
What is the product code of K090406?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.