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FDA 510(k) Application Details - K090285
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K090285
Device Name
System, Monitoring, Perinatal
Applicant
HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH WALES CF24 5HN GB
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Contact
GRAHAM BOOTH
Other 510(k) Applications for this Contact
Regulation Number
884.2740
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Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/2009
Decision Date
07/15/2009
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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