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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 K992607
Device Name SONICAID SYSTEM 8002
Applicant
OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/03/1999
Decision Date 04/27/2001
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
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