Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems
FDA 510(k) K043219 · Interacoustics AS
510(k) numberK043219
Submission
- Device name
- Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems
- Applicant
- Interacoustics AS
Minnesota, MN, US - Received
- November 22, 2004
- Decision date
- February 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K090406 | EP15 Software Module, EP25 Software ModuleEWO · Traditional | 07/22/2009SE |
| 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 |
Questions and answers
When was Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems cleared by the FDA?
Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems (K043219) received a 510(k) decision of Substantially Equivalent on February 4, 2005, 74 days after the submission was received.
What is the product code of K043219?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.