← Product Code [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN) · K002104

# COMBINED PHYSIOLOGICAL MONITORING SYSTEM (K002104)

_Maryrose Cusimano, Ph.D. & Scott Zeff · IKN · Oct 10, 2000 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K002104

## Device Facts

- **Applicant:** Maryrose Cusimano, Ph.D. & Scott Zeff
- **Product Code:** [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN.md)
- **Decision Date:** Oct 10, 2000
- **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/K002104](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K002104)

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