OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00


Device Classification Name

system, monitoring, perinatal

510(k) Number K081203
Device Name OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
hewlett-packard str. 2
boeblingen
baden-wuerttemberg, 

DE

d-71034

Applicant Contact michael asmalsky
Correspondent
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
hewlett-packard str. 2
boeblingen
baden-wuerttemberg, 

DE

d-71034

Correspodent Contact michael asmalsky
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 04/28/2008
Decision Date 05/28/2008
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