Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K150117 |
Device Name |
Medtronic Patient Asistant |
Applicant |
Medtronic, Inc. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
Eric Kalmes |
Correspondent |
Medtronic, Inc. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Eric Kalmes |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 01/20/2015 |
Decision Date | 05/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|