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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 K140535
Device Name PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
Applicant
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Applicant Contact MICHAEL ASMALSKY
Correspondent
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Correspondent Contact MICHAEL ASMALSKY
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
DQA   DRG   DRQ   DRS   DRT  
DSA   DSF   DSI   DSJ   DSK   DXG  
DXN   DXQ   FLL   HFM   HFN   HGL  
JOM   MSX  
Date Received03/04/2014
Decision Date 11/25/2014
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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