Device Classification Name |
System, Network And Communication, Physiological Monitors
|
510(k) Number |
K001972 |
Device Name |
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK |
Applicant |
VISICU, INC. |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
CAROL PATTERSON |
Correspondent |
VISICU, INC. |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
CAROL PATTERSON |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 06/28/2000 |
Decision Date | 10/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|