Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K141706 |
Device Name |
ECARE COORDINATOR (ECC) |
Applicant |
VISICU, INC. |
217 E. REDWOOD ST., STE. 1900 |
BALTIMORE,
MD
21202
|
|
Applicant Contact |
CHRIS FERGUSON |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 06/24/2014 |
Decision Date | 09/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|