Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K160899 |
Device Name |
CoVa Monitoring System 2 |
Applicant |
TOSENSE, INC. |
4225 EXECUTIVE SQUARE |
SUITE 570 |
la jolla,
CA
92037
|
|
Applicant Contact |
susan pede |
Correspondent |
TOSENSE, INC. |
4225 EXECUTIVE SQUARE |
SUITE 570 |
la jolla,
CA
92037
|
|
Correspondent Contact |
susan pede |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/01/2016 |
Decision Date | 06/22/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Clinical Trials |
NCT02337790 NCT02719301
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|