Device Classification Name |
ophthalmoscope, battery-powered
|
510(k) Number |
K852334 |
Device Name |
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) |
Applicant |
DESIGN MED. CORP. |
P.O. BOX 782 |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
CONRAD M SWARTZ |
Correspondent |
DESIGN MED. CORP. |
P.O. BOX 782 |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
CONRAD M SWARTZ |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 05/31/1985 |
Decision Date | 06/18/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|