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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 K111083
Device Name PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
Applicant
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Applicant Contact MICHAEL ASMALSKY
Correspondent
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Correspondent Contact MICHAEL ASMALSKY
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received04/19/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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