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 Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K973025
Device Name FLUID CENTURION (4-100-00)
Applicant
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN,  IL  60123
Applicant Contact CASEY KUREK
Correspondent
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN,  IL  60123
Correspondent Contact CASEY KUREK
Regulation Number880.2420
Classification Product Code
FLN  
Date Received08/14/1997
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-