Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K163512 |
Device Name |
Zio AT ECG Monitoring System |
Applicant |
IRHYTHM TECHNOLOGIES, INC. |
650 TOWNSEND STREET |
SUITE 380 |
san francisco,
CA
94103
|
|
Applicant Contact |
rich laguna |
Correspondent |
IRHYTHM TECHNOLOGIES, INC. |
650 TOWNSEND STREET |
SUITE 380 |
san francisco,
CA
94103
|
|
Correspondent Contact |
rich laguna |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/15/2016 |
Decision Date | 06/02/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|