Product Code: MSG FDA class 2 21 CFR 886.1570

Ophthalmoscopes, Replacement Batteries, Hand-Held

Ophthalmic

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.

510(k)s
2
FEI Numbers
7
Registration Numbers
7
Unique Applicants
1
Years Active
0

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K971108 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
K970268 ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY

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.