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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 K023618
Device Name SONICAID ONE
Applicant
OXFORD INSTRUMENTS MEDICAL LTD.
MANOR WAY
OLD WOKING, SURREY,  GB GU22 9JU
Applicant Contact MICHAEL EDWARDS
Correspondent
OXFORD INSTRUMENTS MEDICAL LTD.
MANOR WAY
OLD WOKING, SURREY,  GB GU22 9JU
Correspondent Contact MICHAEL EDWARDS
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received10/29/2002
Decision Date 01/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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