Teca/Medelec Audiostar
FDA 510(k) K863156 · Teca, Inc.
510(k) numberK863156
Submission
- Device name
- Teca/Medelec Audiostar
- Applicant
- Teca, Inc.
Pleasantiville, NY, US - Received
- August 18, 1986
- Decision date
- February 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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 |
|---|---|---|
| K962283 | EEG ElectrodesGXY · Traditional | 12/16/1996SE |
| K903731 | Sapphire Series 1P, 1L, 2L, and 2MEGWF · Traditional | 02/04/1991SE |
| K903004 | EE1114, 1118, 1121 Electro-EncephalographGWQ · Traditional | 11/15/1990SE |
| K896666 | P460, DG32 ElectroencephalographGWQ · Traditional | 02/16/1990SE |
| K894889 | Teca Neuromapper 386OLT · Traditional | 12/22/1989SE |
| K894088 | Teca Neuromapper 1620, Brain MapperOLT · Traditional | 11/15/1989SE |
| K890881 | Teca 1A96, 1A97 and 1A98 ElectroencephalographsGWQ · Traditional | 03/23/1989SE |
| K884870 | Teca/Medelec 'Concept' P420GWF · Traditional | 02/23/1989SE |
| K880593 | Teca/Medelec MistralGWE · Traditional | 04/06/1988SE |
| K872931 | Teca/Medelec TTT Thermal Threshold TesterLLN · Traditional | 11/16/1987SE |
Questions and answers
When was Teca/Medelec Audiostar cleared by the FDA?
Teca/Medelec Audiostar (K863156) received a 510(k) decision of Substantially Equivalent on February 3, 1987, 169 days after the submission was received.
What is the product code of K863156?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.