← Product Code [GWK](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK) · K904328

# VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (K904328)

_Telediagnostic Systems, Inc. · GWK · Jun 18, 1991 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K904328

## Device Facts

- **Applicant:** Telediagnostic Systems, Inc.
- **Product Code:** [GWK](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK.md)
- **Decision Date:** Jun 18, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1845
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K904328](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K904328)

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