Device Classification Name |
Electrocardiograph
|
510(k) Number |
K130921 |
FOIA Releasable 510(k) |
K130921
|
Device Name |
ALIVECOR HEART MONITOR OTC |
Applicant |
ALIVECOR, INC. |
30 MAIDEN LANE, 6TH FLOOR |
SAN FRANCISCO,
CA
94108
|
|
Applicant Contact |
MICHAEL RIGHTER |
Correspondent |
ALIVECOR, INC. |
30 MAIDEN LANE, 6TH FLOOR |
SAN FRANCISCO,
CA
94108
|
|
Correspondent Contact |
MICHAEL RIGHTER |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 04/03/2013 |
Decision Date | 02/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|