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FDA 510(k) Application Details - K992607
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K992607
Device Name
System, Monitoring, Perinatal
Applicant
OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/1999
Decision Date
04/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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