Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K121689 |
Device Name |
VITASCAN LT SCANMASTER |
Applicant |
VITACON MEDICAL INC. |
4020 Viking Way |
Unit 130 |
Richmond,
CA
V6V 2L4
|
|
Applicant Contact |
RON EVANS |
Correspondent |
VITACON MEDICAL INC. |
4020 Viking Way |
Unit 130 |
Richmond,
CA
V6V 2L4
|
|
Correspondent Contact |
RON EVANS |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 09/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|