510(k) Premarket Notification Database
Device Classification Name |
system, image processing, radiological
|
510(k) Number | K973065 |
Device Name | REALVIEW TELEMEDICINE SYSTEM |
Applicant |
VCOM SYSTEMS, INC.
|
809 north dixie hwy., #200 |
west palm beach,
FL
33401 |
|
Contact | wayne b jacobs |
Regulation Number | 892.2050 |
Classification Product Code |
|
Date Received | 08/18/1997 |
Decision Date | 11/13/1997 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Radiology
|
Review Advisory Committee |
Radiology
|
Statement/Summary/Purged Status |
Statement/purged 510(k)
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|