Chartr Ep
FDA 510(k) K960097 · Ics Medical Corp.
510(k) numberK960097
Submission
- Device name
- Chartr Ep
- Applicant
- Ics Medical Corp.
Schaumburg, IL, US - Received
- January 11, 1996
- Decision date
- February 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GWJ
| 510(k) | Device | Applicant | Decision |
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| K242954 | Integrity V500 (Integrity, Integrity with VEMP)GWJ · Traditional | Vivosonic, Inc. | 12/19/2024SE |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 03/08/2024SE |
| K220139 | QScreenGWJ · Traditional | Path Medical GmbH | 08/03/2022SE |
| K211147 | ALGO 7iGWJ · Traditional | Path Medical GmbH | 10/14/2021SE |
| K193033 | GSI Audera ProGWJ · Traditional | Grason Stadler | 04/24/2020SE |
| 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 |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | Gn Otometrics | 02/27/2014SE |
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 |
| 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 |
| 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 Chartr Ep cleared by the FDA?
Chartr Ep (K960097) received a 510(k) decision of Substantially Equivalent on February 21, 1997, 407 days after the submission was received.
What is the product code of K960097?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.