Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K183319 |
Device Name |
Triangle System |
Applicant |
AliveCor, Inc. |
444 Castro Street, Suite 600 |
Mountain View,
CA
94041
|
|
Applicant Contact |
Prabhu Raghavan |
Correspondent |
AliveCor, Inc. |
444 Castro Street, Suite 600 |
Mountain View,
CA
94041
|
|
Correspondent Contact |
Prabhu Raghavan |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/30/2018 |
Decision Date | 05/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|