SMARTSCREENER-PLUS2
FDA 510(k) K090579 · Intelligent Hearing Systems
510(k) numberK090579
Submission
- Device name
- SMARTSCREENER-PLUS2
- Applicant
- Intelligent Hearing Systems
Miami, FL, US - Received
- March 3, 2009
- Decision date
- July 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K163326 | SmartEPGWJ · Traditional | 09/29/2017SE |
| K073384 | Smart Coupler, Model M015401GWJ · Traditional | 02/28/2008SE |
| K070608 | Smartep, Model M010000GWJ · Traditional | 07/18/2007SE |
| 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 SMARTSCREENER-PLUS2 cleared by the FDA?
SMARTSCREENER-PLUS2 (K090579) received a 510(k) decision of Substantially Equivalent on July 7, 2009, 126 days after the submission was received.
What is the product code of K090579?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.