Model 320 Two Channel Audiometer
FDA 510(k) K863984 · Virtual Corp.
510(k) numberK863984
Submission
- Device name
- Model 320 Two Channel Audiometer
- Applicant
- Virtual Corp.
Portland, OR, US - Received
- October 14, 1986
- Decision date
- November 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K960500 | The Virtual M-332EWD · Traditional | 04/03/1996SE |
| K934715 | Model 222 Clinical AudiometerEWO · Traditional | 05/10/1994SE |
| K930203 | Model 322 Clinical AudiometerEWD · Traditional | 07/08/1993SE |
| K926574 | Model 330 Screening Audio Meter, ModifiedGWJ · Traditional | 03/29/1993SE |
| K911689 | Model 330 Screening AudiometerEWO · Traditional | 10/21/1991SE |
| K896301 | Model 340 Probe Mic SystemETW · Traditional | 01/16/1990SE |
| K895443 | Model 210 Impedance SystemETY · Traditional | 01/16/1990SE |
| K853863 | Model 310 Impedance SystemETY · Traditional | 12/18/1985SE |
Questions and answers
When was Model 320 Two Channel Audiometer cleared by the FDA?
Model 320 Two Channel Audiometer (K863984) received a 510(k) decision of Substantially Equivalent on November 18, 1986, 35 days after the submission was received.
What is the product code of K863984?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.