Device Classification Name |
ophthalmoscope, battery-powered
|
510(k) Number |
K841292 |
Device Name |
SPECTACLE INDIRECT OPHTHALMOSCOPE |
Applicant |
KELLER INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KELLER INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 03/29/1984 |
Decision Date | 05/09/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|