Device Classification Name |
device, storage, images, ophthalmic |
|||
---|---|---|---|---|
510(k) Number | K021787 | |||
Device Name | VISUCAM | |||
Original Applicant |
|
|||
Original Contact | dionne n labatore | |||
Regulation Number | 892.2010 | |||
Classification Product Code |
|
|||
Subsequent Product Code |
|
|||
Date Received | 05/30/2002 | |||
Decision Date | 06/21/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Radiology |
|||
510k Review Panel |
Ophthalmic |
|||
summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |