Cochlea-Scan / Cochlea-Scan Plus
FDA 510(k) K061744 · Bio-Logic Systems Corp.
510(k) numberK061744
Submission
- Device name
- Cochlea-Scan / Cochlea-Scan Plus
- Applicant
- Bio-Logic Systems Corp.
Mudelein, IL, US - Received
- June 21, 2006
- Decision date
- September 15, 2006
- 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 |
|---|---|---|
| K122496 | Audx Pro Otoacoustic Emissions Measurement SystemEWO · Traditional | 11/01/2012SE |
| K121512 | Scout Sport Otoacoustic Emissions Measurement SystemEWO · Traditional | 07/26/2012SE |
| K073626 | Bio-Logic Master II Evoked Response SystemGWJ · Special | 02/05/2008SE |
| K052066 | Ceegraph/Sleepscan Netlink TravelerOLV · Special | 08/26/2005SE |
| K031352 | Bio-Logic Insert EarphonesEWO · Traditional | 07/16/2003SE |
| K030907 | Stacked Abr for Navigator ProGWJ · Special | 05/09/2003SE |
| K031009 | Modification to Bio-Logic Evoked Potential (Ep) SystemGWJ · Special | 04/28/2003SE |
| K021895 | Bio-Logic Master Evoked Response SystemGWJ · Special | 07/01/2002SE |
| K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsEWO · Special | 06/27/2002SE |
| K021215 | Bio-Logic Abaer CubGWJ · Special | 05/15/2002SE |
Questions and answers
When was Cochlea-Scan / Cochlea-Scan Plus cleared by the FDA?
Cochlea-Scan / Cochlea-Scan Plus (K061744) received a 510(k) decision of Substantially Equivalent on September 15, 2006, 86 days after the submission was received.
What is the product code of K061744?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.