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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 K100420
Device Name PHILIPS OBTRACEVUE MODEL SW REV. G.00
Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
boeblingen,  DE 71034
Applicant Contact michael asmalsky
Correspondent
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
boeblingen,  DE 71034
Correspondent Contact michael asmalsky
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
DSJ  
Date Received02/16/2010
Decision Date 07/26/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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