The Screener Gsi 55 Abr Screener
FDA 510(k) K870030 · Grason-Stadler, Inc.
510(k) numberK870030
Submission
- Device name
- The Screener Gsi 55 Abr Screener
- Applicant
- Grason-Stadler, Inc.
Littleton, MA, US - Received
- January 5, 1987
- Decision date
- March 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K193033 | GSI Audera ProGWJ · Traditional | 04/24/2020SE |
| K180287 | GSI CortiEWO · Traditional | 05/11/2018SE |
| K172403 | GSI NovusEWO · Traditional | 10/20/2017SE |
| K000097 | Gsi 2000 Middle Ear AnalyzerETY · Abbreviated | 04/12/2000SE |
| K974237 | Gsi 70 Audiopath ScreenerEWO · Traditional | 02/10/1998SE |
| K970324 | Gsi SA60 Dpoae SystemETW · Traditional | 06/06/1997SE |
| K953684 | Gsi 61 Clinical AudiometerEWO · Traditional | 10/27/1995SE |
| K951759 | Gsi 65 Computerized AudiometerEWO · Traditional | 07/06/1995SE |
| K902540 | Gsi 17 Screening AudiometerEWO · Traditional | 07/13/1990SE |
| K890124 | ILO88 Otodynamic Analyzer Screening AudiometerEWO · Traditional | 07/14/1989SE |
Questions and answers
When was The Screener Gsi 55 Abr Screener cleared by the FDA?
The Screener Gsi 55 Abr Screener (K870030) received a 510(k) decision of Substantially Equivalent on March 13, 1987, 67 days after the submission was received.
What is the product code of K870030?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.