H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
Device Facts
| Record ID | K946043 |
|---|---|
| Device Name | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG |
| Applicant | Rudolf Riester GmbH & Co. KG |
| Product Code | ERA · Ear, Nose, Throat |
| Decision Date | Mar 8, 1995 |
| Decision | SESK |
| 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.
