Ophthalmoscopes, Replacement Batteries, Hand-Held
Replacement Batteries for Hand-Held Ophthalmoscopes are power supply accessories designed to maintain the operation of handheld ophthalmoscopes, which are instruments used by clinicians to examine the interior of the eye including the retina, optic disc, and blood vessels. These accessories are FDA Class 2, requiring 510(k) premarket clearance, with product code MSG under 21 CFR 886.1570 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MSG
- Device Class
- FDA class 2
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971108 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P | May 06, 1997 | Substantially Equivalent | Alexander Mfg. Co. |
| K970268 | ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY | Mar 31, 1997 | Substantially Equivalent | Alexander Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.