← Product Code [GWK](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK) · K801670

# NDI-IKE EMG (K801670)

_Neurodiagnostics, Inc. · GWK · Aug 4, 1980 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K801670

## Device Facts

- **Applicant:** Neurodiagnostics, Inc.
- **Product Code:** [GWK](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK.md)
- **Decision Date:** Aug 4, 1980
- **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/K801670](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K801670)

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