Titan
FDA 510(k) K130795 · Interacoustics A/S
510(k) numberK130795
Submission
- Device name
- Titan
- Applicant
- Interacoustics A/S
Assens, DK - Received
- March 22, 2013
- Decision date
- June 20, 2013
- 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 |
|---|---|---|
| K200534 | VisualEyesGWN · Traditional | 08/12/2020SE |
| K200529 | OrionLXV · Traditional | 08/12/2020SE |
| K192652 | TRVLXV · Traditional | 05/27/2020SE |
| K191372 | LyraEWO · Traditional | 07/15/2019SE |
| K173567 | SeraEWO · Traditional | 02/14/2018SE |
| K163149 | VisualEyesGWN · Traditional | 04/26/2017SE |
| K162037 | Eclipse with VEMPGWJ · Traditional | 03/23/2017SE |
| K152112 | VisualEyesGWN · Traditional | 12/29/2015SE |
| K151616 | AT235ETY · Special | 07/15/2015SE |
| K131681 | Eyeseecam VhitGWN · Traditional | 09/06/2013SE |
Questions and answers
When was Titan cleared by the FDA?
Titan (K130795) received a 510(k) decision of Substantially Equivalent on June 20, 2013, 90 days after the submission was received.
What is the product code of K130795?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.