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FDA 510(k) Application Details - K970456
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K970456
Device Name
System, Monitoring, Perinatal
Applicant
HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG 71034 DE
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Contact
MIKE HUDON
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
02/06/1997
Decision Date
10/03/1997
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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