Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K042001 |
Device Name |
PANORAMIC 200A |
Applicant |
OPTOS PLC |
555 THIRTEENTH ST. N.W. |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
OPTOS PLC |
555 THIRTEENTH ST. N.W. |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 07/26/2004 |
Decision Date | 10/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|