Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K870527 |
Device Name |
CARDIOTEAM |
Applicant |
CARDIAC NETWORK, INC. |
100 CHOPIN PLAZA |
SUITE 3110 |
MIAMI,
FL
33131
|
|
Applicant Contact |
INGRID FORTUN |
Correspondent |
CARDIAC NETWORK, INC. |
100 CHOPIN PLAZA |
SUITE 3110 |
MIAMI,
FL
33131
|
|
Correspondent Contact |
INGRID FORTUN |
Regulation Number | 870.2920 |
Classification Product Code |
|
Date Received | 02/09/1987 |
Decision Date | 04/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|