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FDA 510(k) Application Details - K091251
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K091251
Device Name
System, Monitoring, Perinatal
Applicant
CERNER CORP.
2800 ROCKCREEK PKWY.
KANSAS CITY, MO 64117 US
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Contact
SHELLEY S LOOBY
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
04/29/2009
Decision Date
08/25/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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