Device Classification Name |
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
|
510(k) Number |
K192593 |
Device Name |
Confirm Rx Insertable Cardiac Monitor |
Applicant |
Abbott |
15900 Valley View Ct. |
Sylmar,
CA
91342
|
|
Applicant Contact |
Laura Sparks |
Correspondent |
Abbott |
15900 Valley View Ct. |
Sylmar,
CA
91342
|
|
Correspondent Contact |
Laura Sparks |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/20/2019 |
Decision Date | 10/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|