Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K130971 |
Device Name |
OPTUM TELEHEALTH APPLICATION |
Applicant |
OPTUMHEALTH CARE SOLUTIONS, INC. |
4 INNOVATION DR |
DUNDAS, ON,
CA
L9H 7P3
|
|
Applicant Contact |
ROSHANA AHMED, MA, RAC |
Correspondent |
OPTUMHEALTH CARE SOLUTIONS, INC. |
4 INNOVATION DR |
DUNDAS, ON,
CA
L9H 7P3
|
|
Correspondent Contact |
ROSHANA AHMED, MA, RAC |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/08/2013 |
Decision Date | 10/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|