Device Classification Name |
photostimulator, ac-powered
|
510(k) Number |
K003442 |
Device Name |
MODIFICATION TO EDI VERIS SYSTEM |
Applicant |
ELECTRO-DIAGNOSTIC IMAGING, INC. |
2081 LONGDEN CIRCLE |
LOS ALTOS,
CA
94024
|
|
Applicant Contact |
SHEILA W PICKERING |
Correspondent |
ELECTRO-DIAGNOSTIC IMAGING, INC. |
2081 LONGDEN CIRCLE |
LOS ALTOS,
CA
94024
|
|
Correspondent Contact |
SHEILA W PICKERING |
Regulation Number | 886.1630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/06/2000 |
Decision Date | 05/04/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|