Device Classification Name |
recorder, event, implantable cardiac, (with arrhythmia detection)
|
510(k) Number |
K160809 |
Device Name |
Reveal LINQ |
Applicant |
MEDTRONIC, INC. |
8200 CORAL SEA ST NW |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
Dianna L Johannson |
Correspondent |
MEDTRONIC, INC. |
8200 CORAL SEA ST NW |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
Dianna L Johannson |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/24/2016 |
Decision Date | 05/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|