Device Classification Name |
electrocardiograph
|
510(k) Number |
K130409 |
Device Name |
ALIVECOR HEART MONITOR |
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 | 02/19/2013 |
Decision Date | 09/06/2013 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|