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FDA 510(k) Application Details - K150901
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K150901
Device Name
System, Monitoring, Perinatal
Applicant
EDAN INSTRUMENTS, INC.
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI ROAD #1019
SHENZHEN 518067 CN
Other 510(k) Applications for this Company
Contact
Queena Chen
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
04/03/2015
Decision Date
07/01/2015
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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