← Product Code [KHH](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH) · K931608

# NCA-200 (K931608)

_Ics Medical Corp. · KHH · Jun 22, 1993 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K931608

## Device Facts

- **Applicant:** Ics Medical Corp.
- **Product Code:** [KHH](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH.md)
- **Decision Date:** Jun 22, 1993
- **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/KHH/K931608](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KHH/K931608)

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