MODEL 2120IS SERIES MATERNAL/FETAL MONITOR


Device Classification Name

system, monitoring, perinatal

510(k) Number K021135
Device Name MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 barnes park rd., north
wallingford, 
CT 
06492

Original Contact joelle neider
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 04/09/2002
Decision Date 05/09/2002
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