GSI Novus
FDA 510(k) K172403 · Grason-Stadler, Inc.
510(k) numberK172403
Submission
- Device name
- GSI Novus
- Applicant
- Grason-Stadler, Inc.
Eden Prairie, MN, US - Received
- August 9, 2017
- Decision date
- October 20, 2017
- 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 |
| 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 |
|---|---|---|
| K193033 | GSI Audera ProGWJ · Traditional | 04/24/2020SE |
| K180287 | GSI CortiEWO · Traditional | 05/11/2018SE |
| K000097 | Gsi 2000 Middle Ear AnalyzerETY · Abbreviated | 04/12/2000SE |
| K974237 | Gsi 70 Audiopath ScreenerEWO · Traditional | 02/10/1998SE |
| K970324 | Gsi SA60 Dpoae SystemETW · Traditional | 06/06/1997SE |
| K953684 | Gsi 61 Clinical AudiometerEWO · Traditional | 10/27/1995SE |
| K951759 | Gsi 65 Computerized AudiometerEWO · Traditional | 07/06/1995SE |
| K902540 | Gsi 17 Screening AudiometerEWO · Traditional | 07/13/1990SE |
| K890124 | ILO88 Otodynamic Analyzer Screening AudiometerEWO · Traditional | 07/14/1989SE |
| K870030 | The Screener Gsi 55 Abr ScreenerGWJ · Traditional | 03/13/1987SE |
Questions and answers
When was GSI Novus cleared by the FDA?
GSI Novus (K172403) received a 510(k) decision of Substantially Equivalent on October 20, 2017, 72 days after the submission was received.
What is the product code of K172403?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.