OPTIEAR
Device Facts
| Record ID | K920322 |
|---|---|
| Device Name | OPTIEAR |
| Applicant | Nankivell Industries, Inc. |
| Product Code | ERA · Ear, Nose, Throat |
| Decision Date | Apr 23, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4770 |
| Device Class | Class 1 |
Regulatory Classification
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.
