MODEL 250CX SERIES MATERNAL/FETAL MONITOR


Device Classification Name

system, monitoring, perinatal

510(k) Number K072976
Device Name MODEL 250CX SERIES MATERNAL/FETAL MONITOR
Applicant
GE HEALTHCARE
8880 gorman rd
laurel, 
MD 
20723

Applicant Contact agata smieja
Correspondent
GE HEALTHCARE
8880 gorman rd
laurel, 
MD 
20723

Correspodent Contact agata smieja
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 10/25/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No