Ics Medical Chartr Oae with Tymp
FDA 510(k) K011181 · Ics Medical Corp.
510(k) numberK011181
Submission
- Device name
- Ics Medical Chartr Oae with Tymp
- Applicant
- Ics Medical Corp.
Schaumburg, IL, US - Received
- April 18, 2001
- Decision date
- June 25, 2001
- 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
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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 |
|---|---|---|
| K031986 | Ics Medical Chartr Ep with Assr and Chartr Oae SystemsEWO · Special | 07/24/2003SE |
| K013060 | Ics Medical Model VG-30 Video GogglesGWN · Traditional | 12/10/2001SE |
| K002985 | Ics Medical Chartr Ep and Chartr Oae SystemsGWJ · Traditional | 12/13/2000SE |
| K991497 | Ics Medical Chartr Eng/Vng Diagnostic SystemGWN · Traditional | 07/28/1999SE |
| K972631 | Ics Medical Vemr Video Eye Movement RecorderGWN · Traditional | 09/22/1997SE |
| K960097 | Chartr EpGWJ · Traditional | 02/21/1997SE |
| K931609 | Chartr Eng SystemGWM · Traditional | 09/26/1995SE |
| K931608 | NCA-200KHH · Traditional | 06/22/1993SE |
| K925237 | Automatic Caloric Irrigation SystemKHH · Traditional | 05/05/1993SE |
| K881630 | Automatic Caloric Irrigation SystemKHH · Traditional | 06/21/1988SE |
Questions and answers
When was Ics Medical Chartr Oae with Tymp cleared by the FDA?
Ics Medical Chartr Oae with Tymp (K011181) received a 510(k) decision of Substantially Equivalent on June 25, 2001, 68 days after the submission was received.
What is the product code of K011181?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.