PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50


Device Classification Name

system, monitoring, perinatal

510(k) Number K111083
Device Name PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
hewlett-packard str.2
boeblingen, 

DE

d 71034

Applicant Contact michael asmalsky
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
hewlett-packard str.2
boeblingen, 

DE

d 71034

Correspodent Contact michael asmalsky
Regulation Number 884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received 04/19/2011
Decision Date 08/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls