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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 K002150
Device Name SONICAID FM820, SONICAID FM830
Applicant
OXFORD INSTRUMENTS
MANOR WAY
OLD WOKING, SURREY,  GB GU22 9JU
Applicant Contact STEVE VALE
Correspondent
OXFORD INSTRUMENTS
MANOR WAY
OLD WOKING, SURREY,  GB GU22 9JU
Correspondent Contact STEVE VALE
Regulation Number884.2740
Classification Product Code
HGM  
Date Received07/17/2000
Decision Date 03/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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