CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE


Device Classification Name

system, monitoring, perinatal

510(k) Number K111614
Device Name CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
Applicant
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 w. nw highway
barrington, 
IL 
60010

Applicant Contact jeme wallace
Correspondent
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 w. nw highway
barrington, 
IL 
60010

Correspodent Contact jeme wallace
Regulation Number 884.2740
Classification Product Code
HGM  
Subsequent Product Code
MSX  
Date Received 06/08/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls