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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 K062137
Device Name MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN, BADEN-WTTBG,  DE D 71034
Applicant Contact MARKUS STACHA
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN, BADEN-WTTBG,  DE D 71034
Correspondent Contact MARKUS STACHA
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
DXN  
Date Received07/26/2006
Decision Date 08/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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