GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
Device Facts
| Record ID | K941662 |
|---|---|
| Device Name | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT |
| Applicant | Gm Engineering, Inc. |
| Product Code | EQH · Ear, Nose, Throat |
| Decision Date | Jul 20, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4350 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.
