Device Classification Name |
electrocardiograph
|
510(k) Number |
K122356 |
FOIA Releasable 510(k) |
K122356
|
Device Name |
ALIVECOR HEART MONITOR FOR IPHONE |
Applicant |
ALIVECOR, INC. |
140 GEARY STREET |
SUITE 500 |
SAN FRANCISCO,
CA
94108
|
|
Applicant Contact |
MICHAEL RIGHTER |
Correspondent |
ALIVECOR, INC. |
140 GEARY STREET |
SUITE 500 |
SAN FRANCISCO,
CA
94108
|
|
Correspondent Contact |
MICHAEL RIGHTER |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 08/03/2012 |
Decision Date | 11/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|