Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K143359 |
Device Name |
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector |
Applicant |
LifeWatch Technologies Ltd. |
2 Pekeris St. |
Rehovot,
IL
7670202
|
|
Applicant Contact |
Asher Kassel |
Correspondent |
Life Watch |
10255 W Higgins Road, Suite 100 |
Chicago,
IL
60018
|
|
Correspondent Contact |
Stephen Slavens |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/24/2014 |
Decision Date | 09/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|