Ics Medical Chartr Ep and Chartr Oae Systems
FDA 510(k) K002985 · Ics Medical Corp.
510(k) numberK002985
Submission
- Device name
- Ics Medical Chartr Ep and Chartr Oae Systems
- Applicant
- Ics Medical Corp.
Schaumburg, IL, US - Received
- September 25, 2000
- Decision date
- December 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K220139 | QScreenGWJ · Traditional | Path Medical GmbH | 08/03/2022SE |
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| K163326 | SmartEPGWJ · Traditional | Intelligent Hearing Systems | 09/29/2017SE |
| K162037 | Eclipse with VEMPGWJ · Traditional | Interacoustics A/S | 03/23/2017SE |
| K143670 | Ics Chartr Ep 200 with VempGWJ · Traditional | Gn Otometrics A/S | 10/23/2015SE |
| K141446 | Echo-Screen III Pro Hearing Screener with Barcode Scanner, Echo-Screen III Pro Hearing…GWJ · Special | Natus Medical Incorporated | 08/22/2014SE |
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More from Gn Otometrics
| 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 |
| K011181 | Ics Medical Chartr Oae with TympEWO · Traditional | 06/25/2001SE |
| 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 Ep and Chartr Oae Systems cleared by the FDA?
Ics Medical Chartr Ep and Chartr Oae Systems (K002985) received a 510(k) decision of Substantially Equivalent on December 13, 2000, 79 days after the submission was received.
What is the product code of K002985?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.