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FDA 510(k) Application Details - K112159
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K112159
Device Name
System, Monitoring, Perinatal
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 ST
HIALEAH, FL 33010 US
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Contact
JORGE MILLAN
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
07/27/2011
Decision Date
09/21/2011
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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