Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K171029 |
Device Name |
eCareCoordinator |
Applicant |
Visicu Inc. |
217 East Redwood St. Suite 1900 |
Baltimore,
MD
21202
|
|
Applicant Contact |
Daniel R. Plonski |
Correspondent |
Visicu Inc. |
217 East Redwood St. Suite 1900 |
Baltimore,
MD
21202
|
|
Correspondent Contact |
Milind Gramopadhye |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 04/06/2017 |
Decision Date | 07/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|