← Product Code [ERA](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA) · K840593

# DISPOSA-SPEC (K840593)

_Plasti-Products, Inc. · ERA · Jul 13, 1984 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K840593

## Device Facts

- **Applicant:** Plasti-Products, Inc.
- **Product Code:** [ERA](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA.md)
- **Decision Date:** Jul 13, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4770
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K840593](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERA/K840593)

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