← Product Code [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN) · K842612

# COMPACT AUDITORY (K842612)

_Nicolet Biomedical Instruments · IKN · Jul 20, 1984 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K842612

## Device Facts

- **Applicant:** Nicolet Biomedical Instruments
- **Product Code:** [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN.md)
- **Decision Date:** Jul 20, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1375
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K842612](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K842612)

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