← Product Code [ETP](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP) · K813552

# MODEL 3000C CALORIC IRRIGATOR (K813552)

_Life-Tech Intl., Inc. · ETP · Feb 22, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K813552

## Device Facts

- **Applicant:** Life-Tech Intl., Inc.
- **Product Code:** [ETP](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP.md)
- **Decision Date:** Feb 22, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1800
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K813552](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K813552)

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