MSG · Ophthalmoscopes, Replacement Batteries, Hand-Held
Ophthalmic · 21 CFR 886.1570 · Class 2
Overview
| Product Code | MSG |
|---|---|
| Device Name | Ophthalmoscopes, Replacement Batteries, Hand-Held |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
Classification Rationale
Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971108 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P | Alexander Mfg. Co. | May 6, 1997 | SESE |
| K970268 | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY | Alexander Mfg. Co. | Mar 31, 1997 | SESE |
Top Applicants
- Alexander Mfg. Co. — 2 clearances
