← Product Code [GWN](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN) · K834148

# PHILLY BOLTS (K834148)

_Philadelphia Medical Specialties · GWN · Feb 10, 1984 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K834148

## Device Facts

- **Applicant:** Philadelphia Medical Specialties
- **Product Code:** [GWN](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN.md)
- **Decision Date:** Feb 10, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1460
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K834148](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K834148)

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