EARBEAR OTOSCOPE
Device Facts
| Record ID | K915537 |
|---|---|
| Device Name | EARBEAR OTOSCOPE |
| Applicant | Earbear Co. |
| Product Code | ERA · Ear, Nose, Throat |
| Decision Date | Jan 24, 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.
