Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K132803 |
Device Name |
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK |
Applicant |
MEDAPPS INC., DBA ALERE CONNECT |
8767 E. VIA DE VENTURA, STE 300 |
SCOTTSDALE,
AZ
85258
|
|
Applicant Contact |
KENT DICKS |
Correspondent |
MEDAPPS INC., DBA ALERE CONNECT |
8767 E. VIA DE VENTURA, STE 300 |
SCOTTSDALE,
AZ
85258
|
|
Correspondent Contact |
KENT DICKS |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/06/2013 |
Decision Date | 12/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|