Model S10VS Visual Stimulator
FDA 510(k) K812061 · Grass Instrument Co.
510(k) numberK812061
Submission
- Device name
- Model S10VS Visual Stimulator
- Applicant
- Grass Instrument Co.
Mchenry, IL, US - Received
- July 21, 1981
- Decision date
- August 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Diopsys, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021807 | Grass-Telefactor AS40 Amplifier SystemOLV · Traditional | 08/29/2002SE |
| K994142 | Grass TS3201/6401 EEG Amplifier SystemOLV · Traditional | 03/06/2000SE |
| K844216 | Grass Model NL Facial Nerve Locator & MonitorJXE · Traditional | 01/18/1985SE |
| K810539 | Model S10CTCM Auditory StimulatorGWJ · Traditional | 03/17/1981SE |
| K771742 | Evoked Response Sys., Model 10GWK · Traditional | 11/22/1977SE |
Questions and answers
When was Model S10VS Visual Stimulator cleared by the FDA?
Model S10VS Visual Stimulator (K812061) received a 510(k) decision of Substantially Equivalent on August 20, 1981, 30 days after the submission was received.
What is the product code of K812061?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.