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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K071800
Device Name PHILIPS AVALON FETAL MONITORS FM20 AND FM30
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN, BADEN-WUERTTEMBERG,  DE D 71034
Applicant Contact MICHAEL ASMALSKY
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN, BADEN-WUERTTEMBERG,  DE D 71034
Correspondent Contact MICHAEL ASMALSKY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received07/02/2007
Decision Date 09/27/2007
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
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