Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K151911 |
FOIA Releasable 510(k) |
K151911
|
Device Name |
WorkMate Claris System, WorkMate Claris System Display Plus |
Applicant |
ST. JUDE MEDICAL |
ONE ST. JUDE MEDICAL DRIVE |
ST. PAUL,
MN
55117
|
|
Applicant Contact |
MELISSA FRANK |
Correspondent |
ST. JUDE MEDICAL |
ONE ST. JUDE MEDICAL DRIVE |
ST. PAUL,
MN
55117
|
|
Correspondent Contact |
MELISSA FRANK |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 07/13/2015 |
Decision Date | 10/22/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|