Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K171406 |
Device Name |
Optum TeleHealth Application |
Applicant |
United Health Group Inc. |
1100 King Street, Buliding 6, Suite 300 |
rye brook,
NY
10573
|
|
Applicant Contact |
donald j. matthews |
Correspondent |
United Health Group Inc. |
1100 King Street, Buliding 6, Suite 300 |
rye brook,
NY
10573
|
|
Correspondent Contact |
donald j. matthews |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/12/2017 |
Decision Date | 08/18/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|