← Product Code [KZM](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM) · K003176

# BIOEMG II AND BIOJVA (K003176)

_Bio-Research Associates, Inc. · KZM · Jan 4, 2001 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM/K003176

## Device Facts

- **Applicant:** Bio-Research Associates, Inc.
- **Product Code:** [KZM](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM.md)
- **Decision Date:** Jan 4, 2001
- **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/DE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM/K003176](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM/K003176)

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