Device Classification Name |
recorder, event, implantable cardiac, (without arrhythmia detection)
|
510(k) Number |
K133481 |
Device Name |
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) |
Applicant |
ST. JUDE MEDICAL, INC. |
645 ALMANOR AVENUE |
SUNNYVALE,
CA
94085 -2927
|
|
Applicant Contact |
Michael McSweeney |
Correspondent |
ST. JUDE MEDICAL, INC. |
645 ALMANOR AVENUE |
SUNNYVALE,
CA
94085 -2927
|
|
Correspondent Contact |
Michael McSweeney |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 11/13/2013 |
Decision Date | 05/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00746564
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|