• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name warmer, thermal, infusion fluid
510(k) Number K121775
Model MODEL 100, MODEL 200 AND 202, MODEL 120 AND 121
Device Name ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
Original Applicant
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
20 campus rd
totowa,  NJ  07512
Original Contact stacie geffner-atiya
Classification Product Code
LGZ  
Date Received06/18/2012
Decision Date 11/28/2012
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-