← Product Code [ETP](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP) · K863615

# ENTHERMO IRRIGATION UNIT (K863615)

_Jedmed Instrument Co. · ETP · Dec 16, 1986 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K863615

## Device Facts

- **Applicant:** Jedmed Instrument Co.
- **Product Code:** [ETP](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP.md)
- **Decision Date:** Dec 16, 1986
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K863615](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETP/K863615)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com