Device Classification Name |
system, network and communication, physiological monitors
|
510(k) Number |
K012171 |
Device Name |
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS |
Applicant |
VISICU, INC. |
2400 BOSTON ST. |
BALTIMORE,
MD
21224
|
|
Applicant Contact |
MICHAEL BRESLOW |
Correspondent |
VISICU, INC. |
2400 BOSTON ST. |
BALTIMORE,
MD
21224
|
|
Correspondent Contact |
MICHAEL BRESLOW |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 07/12/2001 |
Decision Date | 07/24/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|