Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K110205 |
Device Name |
AAIO-7, AAIO WIRLESS |
Applicant |
APPASAMY ASSOCIATES |
20, SBI OFFICERS COLONY |
1ST STREET |
ARUMBAKKAM, CHENNAI,
IN
600 106
|
|
Applicant Contact |
K RENGASAMY |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 886.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/25/2011 |
Decision Date | 02/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|