Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K140933 |
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 |
|
Date Received | 04/11/2014 |
Decision Date | 08/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|