Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K142106 |
Device Name |
DECISIO HEALTH PATIENT DASHBOARD |
Applicant |
DECISIO HEALTH, INC. |
755 N. MATHILDA AVENUE, SUITE 100 |
sunnyvale,
CA
94085
|
|
Applicant Contact |
ronald s warren |
Correspondent |
DECISIO HEALTH, INC. |
755 N. MATHILDA AVENUE, SUITE 100 |
sunnyvale,
CA
94085
|
|
Correspondent Contact |
ronald s warren |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 08/01/2014 |
Decision Date | 01/18/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|