Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K893172 |
Device Name |
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
VAN ARSDALE |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
VAN ARSDALE |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 04/25/1989 |
Decision Date | 06/05/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|