Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K132930 |
Device Name |
MYHEALTHPOINT TELEHEALTH MANAGER |
Applicant |
ENTRA HEALTH SYSTEMS |
3111 Camino Del Rio North |
Suite 101 |
San Diego,
CA
92108
|
|
Applicant Contact |
RICHARD STROBRIDGE |
Correspondent |
ENTRA HEALTH SYSTEMS |
3111 Camino Del Rio North |
Suite 101 |
San Diego,
CA
92108
|
|
Correspondent Contact |
RICHARD STROBRIDGE |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/18/2013 |
Decision Date | 04/14/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|