Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1500](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1500) → ETM — Gustometer, Sterile

# ETM · Gustometer, Sterile

_Ear, Nose, Throat · 21 CFR 874.1500 · Class 1_

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

## Overview

- **Product Code:** ETM
- **Device Name:** Gustometer, Sterile
- **Regulation:** [21 CFR 874.1500](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1500)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A gustometer is a battery-powered device that consists of two electrodes that are intended to be placed on both sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste sensation. It is used for assessing the sense of taste.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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