Interacoustics Clinical Audiometer
FDA 510(k) K941920 · Precision Acoustics Ind., Inc.
510(k) numberK941920
Submission
- Device name
- Interacoustics Clinical Audiometer
- Applicant
- Precision Acoustics Ind., Inc.
New York, NY, US - Received
- April 20, 1994
- Decision date
- September 16, 1994
- 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
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| 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 |
|---|---|---|
| K943607 | Interacoustics Hearing Aid Analyzer MS 40ETW · Traditional | 09/23/1994SE |
| K943066 | Interacoustics Computer Audiometer Ba 20EWO · Traditional | 08/24/1994SE |
| K942008 | Interacoustics Automatic Impedance AudiometerETY · Traditional | 08/24/1994SE |
| K942007 | Interacoustics Clinical Impedance Audiometer AZ26ETY · Traditional | 08/24/1994SE |
| K943065 | Interacoustics Clinical AudiometerEWO · Traditional | 08/17/1994SE |
| K942006 | Interacoustics Diagnostic AudiometerEWO · Traditional | 06/20/1994SE |
| K941848 | Interacoustics. Hearing Aid AnalyzerETW · Traditional | 05/23/1994SE |
| K930260 | Acoustic Analyzer AA30EWO · Traditional | 07/13/1993SE |
Questions and answers
When was Interacoustics Clinical Audiometer cleared by the FDA?
Interacoustics Clinical Audiometer (K941920) received a 510(k) decision of Substantially Equivalent on September 16, 1994, 149 days after the submission was received.
What is the product code of K941920?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.