510(k) Premarket Notification

• 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
• Applicant: VITAL SIGNS, INC., A GE HEALTHCARE COMPANY; 20 campus rd; totowa, NJ 07512
• Contact: stacie geffner-atiya
• Classification Product Code: LGZ
• Date Received: 06/18/2012
• Decision Date: 11/28/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No