Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K171816 |
FOIA Releasable 510(k) |
K171816
|
Device Name |
Kardia Band System |
Applicant |
AliveCor, Inc |
444 Castro Street, Suite 600 |
Mountain View,
CA
94041
|
|
Applicant Contact |
Prabhu Raghavan |
Correspondent |
Experien Group, LLC |
224 Airport Parkway, Suite 250 |
San Jose,
CA
95110
|
|
Correspondent Contact |
Anna Libman |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/19/2017 |
Decision Date | 11/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|