Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K142743 |
Device Name |
AliveCor Heart Monitor |
Applicant |
AliveCor, Inc. |
30 Maiden Lane, 6th Floor |
San Francisco,
CA
94108
|
|
Applicant Contact |
Albert Boniske |
Correspondent |
AliveCor, Inc. |
30 Maiden Lane, 6th Floor |
San Francisco,
CA
94108
|
|
Correspondent Contact |
Albert Boniske |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/24/2014 |
Decision Date | 01/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|