Smartep, Model M010000
FDA 510(k) K070608 · Intelligent Hearing Systems
510(k) numberK070608
Submission
- Device name
- Smartep, Model M010000
- Applicant
- Intelligent Hearing Systems
Miami, FL, US - Received
- March 5, 2007
- Decision date
- July 18, 2007
- 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 |
| 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
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| K163326 | SmartEPGWJ · Traditional | 09/29/2017SE |
| K090579 | SMARTSCREENER-PLUS2GWJ · Traditional | 07/07/2009SE |
| K073384 | Smart Coupler, Model M015401GWJ · Traditional | 02/28/2008SE |
| K063402 | Wick Electrode, Model M019260GXY · Traditional | 12/11/2006SE |
| K061443 | Smart Usblite, Model M011120GWJ · Special | 06/23/2006SE |
| K052060 | Opti-Amp Dc-PoweredGWL · Special | 08/31/2005SE |
| K031051 | Smartep-Assr, Model M811007GWJ · Traditional | 02/20/2004SE |
| K023859 | SmarttroaeEWO · Traditional | 01/08/2003SE |
| K964426 | SmartoaeEWO · Traditional | 02/03/1997SE |
| K925648 | Smart-Screener (Auditory)GWJ · Traditional | 05/11/1993SE |
Questions and answers
When was Smartep, Model M010000 cleared by the FDA?
Smartep, Model M010000 (K070608) received a 510(k) decision of Substantially Equivalent on July 18, 2007, 135 days after the submission was received.
What is the product code of K070608?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.