← Product Code [GWE](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE) · K861069

# TECA NEUROPTO WITH OS-5 STIMULATOR (K861069)

_Teca, Inc. · GWE · Jan 27, 1987 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K861069

## Device Facts

- **Applicant:** Teca, Inc.
- **Product Code:** [GWE](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE.md)
- **Decision Date:** Jan 27, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1890
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K861069](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWE/K861069)

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