Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K060822 |
Device Name |
VANTAGE INDIRECT OPHTHALMOSCOPE |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
EUGENE R VANARSDALE |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
EUGENE R VANARSDALE |
Regulation Number | 886.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/27/2006 |
Decision Date | 05/23/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|