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FDA 510(k) Application Details - K121758
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K121758
Device Name
System, Monitoring, Perinatal
Applicant
CERNER CORP.
10234 MARION PARK DRIVE
KANSAS CITY, MO 64137 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
06/15/2012
Decision Date
10/09/2012
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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