Device Classification Name |
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
|
510(k) Number |
K233562 |
Device Name |
LINQ II Insertable Cardiac Monitor |
Applicant |
Medtronic, Inc. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
Kerry Luyster |
Correspondent |
Medtronic, Inc. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Kerry Luyster |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 11/06/2023 |
Decision Date | 12/06/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|