Device Classification Name |
recorder, event, implantable cardiac, (without arrhythmia detection)
|
510(k) Number |
K173232 |
Device Name |
myMerlin(TM) Mobile Application Model APP1001 |
Applicant |
St. Jude Medical |
15900 Valley View Ct. |
Sylmar,
CA
91342
|
|
Applicant Contact |
Jennifer Dunham |
Correspondent |
St. Jude Medical |
15900 Valley View Ct. |
Sylmar,
CA
91342
|
|
Correspondent Contact |
Jennifer Dunham |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/04/2017 |
Decision Date | 11/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|