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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 K023931
Device Name PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
Applicant
Philips Medical Systems, Inc.
Nederland B.V.
Postbus 10.000
Da Best,  NL 5680
Applicant Contact MARKUS STACHA
Correspondent
Philips Medical Systems, Inc.
Nederland B.V.
Postbus 10.000
Da Best,  NL 5680
Correspondent Contact MARKUS STACHA
Regulation Number884.2740
Classification Product Code
HGM  
Date Received11/26/2002
Decision Date 02/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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