← Product Code [ETF](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF) · K813490

# VERSION OF A CLOSED-FLOW SYS. CALORIC (K813490)

_Thomas M. Foti, M.D. · ETF · Jan 7, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K813490

## Device Facts

- **Applicant:** Thomas M. Foti, M.D.
- **Product Code:** [ETF](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF.md)
- **Decision Date:** Jan 7, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.5300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K813490](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/ETF/K813490)

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