← Product Code [MSG](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG) · K971108

# ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P (K971108)

_Alexander Mfg. Co. · MSG · May 6, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG/K971108

## Device Facts

- **Applicant:** Alexander Mfg. Co.
- **Product Code:** [MSG](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG.md)
- **Decision Date:** May 6, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1570
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG/K971108](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MSG/K971108)

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