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 K850710
Device Name TRAVENOL FLO-GARD 500 IV MONITOR
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact BRIAN STEMBAL
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact BRIAN STEMBAL
Regulation Number880.2420
Classification Product Code
FLN  
Date Received02/22/1985
Decision Date 04/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-