Device Classification Name |
ophthalmoscope, battery-powered
|
510(k) Number |
K032087 |
Device Name |
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
EUGENE VANARSDALE |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
EUGENE VANARSDALE |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 07/07/2003 |
Decision Date | 11/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|