Device Classification Name |
display, cathode-ray tube, medical
|
510(k) Number |
K110085 |
Device Name |
VANTAGE VIEW SYSTEM |
Applicant |
ST. JUDE MEDICAL |
ONE ST JUDE MEDICAL DRIVE |
ST PAUL,
MN
55117 -9913
|
|
Applicant Contact |
KRIS MILLER |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2450
|
Classification Product Code |
|
Date Received | 01/11/2011 |
Decision Date | 01/26/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|