Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K160187 |
Device Name |
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 |
Applicant |
ST. JUDE MEDICAL |
ONE ST. JUDE MEDICAL |
ST. PAUL,
MN
55117
|
|
Applicant Contact |
MELISSA FRANK |
Correspondent |
ST. JUDE MEDICAL |
ONE ST. JUDE MEDICAL |
ST. PAUL,
MN
55117
|
|
Correspondent Contact |
MELISSA FRANK |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 01/27/2016 |
Decision Date | 10/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|