ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER


Device Classification Name

warmer, thermal, infusion fluid

510(k) Number K121775
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

Applicant Contact stacie geffner-atiya
Correspondent
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
20 campus rd
totowa, 
NJ 
07512

Correspodent Contact stacie geffner-atiya
Classification Product Code
LGZ  
Date Received 06/18/2012
Decision Date 11/28/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No