Device Classification Name |
Ophthalmoscope, Battery-Powered
|
510(k) Number |
K093495 |
Device Name |
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS |
Applicant |
AMERICAN DIAGNOSTIC CORP. |
55 COMMERCE DR. |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
MICHAEL FALCO |
Correspondent |
AMERICAN DIAGNOSTIC CORP. |
55 COMMERCE DR. |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
MICHAEL FALCO |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 11/10/2009 |
Decision Date | 11/19/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|