SPECULUM, ENT (S3)
Device Facts
| Record ID | K951050 |
|---|---|
| Device Name | SPECULUM, ENT (S3) |
| Applicant | Pedia Pals, Inc. |
| Product Code | ERA · Ear, Nose, Throat |
| Decision Date | Apr 17, 1995 |
| 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.
