Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K170565 |
Device Name |
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L |
Applicant |
LifeWatch Services, Inc |
10255 W Higgins Road |
Suite 100 |
rosemont,
IL
60018
|
|
Applicant Contact |
stefanie martinez-koenig |
Correspondent |
LifeWatch Services, Inc |
10255 W Higgins Road |
Suite 100 |
rosemont,
IL
60018
|
|
Correspondent Contact |
stefanie martinez-koenig |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/27/2017 |
Decision Date | 08/01/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|