Evoked 3500 Potential System
FDA 510(k) K832084 · Tracor Northern, Inc.
510(k) numberK832084
Submission
- Device name
- Evoked 3500 Potential System
- Applicant
- Tracor Northern, Inc.
Mchenry, IL, US - Received
- June 28, 1983
- Decision date
- August 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Diopsys, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883340 | Neural Magnetic Stimulator, the D190GWF · Traditional | 12/29/1988SE |
| K874733 | Guardian, EEG Brain Monitoring SystemOLT · Traditional | 02/29/1988SE |
| K860968 | TM-3400, Nomad (Modified)GWF · Traditional | 08/18/1986SE |
| K860903 | TM-3600 a Neurodiagnostic SystemGWF · Traditional | 06/05/1986SE |
| K852587 | Cdsa(Color Density, Spectral Arrray)OLT · Traditional | 08/16/1985SE |
| K850109 | Nomad TM-3400GWF · Traditional | 06/04/1985SE |
| K842964 | Photic Stimulator TM-3030-70GWE · Traditional | 12/28/1984SE |
| K822396 | The 3500GWF · Traditional | 09/24/1982SE |
| K810560 | TN-3000 Evoked Response SystemGWF · Traditional | 03/17/1981SE |
Questions and answers
When was Evoked 3500 Potential System cleared by the FDA?
Evoked 3500 Potential System (K832084) received a 510(k) decision of Substantially Equivalent on August 16, 1983, 49 days after the submission was received.
What is the product code of K832084?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.