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FDA 510(k) Application Details - K173941
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K173941
Device Name
System, Monitoring, Perinatal
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str.-2
Boeblingen 71034 DE
Other 510(k) Applications for this Company
Contact
Christoph Krause
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
12/26/2017
Decision Date
09/10/2018
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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