Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Number870.2300
Classification Product Code
MSX  
Date Received06/28/2000
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
-
-