De Novo DEN060006

Device
COMPUTERIZED LABOR MONITORING SYSTEM
Contact
arava hacohen
De Novo number
DEN060006
Product code
NPB
Regulation
884.2800
Classification name
system, monitoring, for progress of labor
Decision
granted (DENG)
Decision date
2007-01-30
Date received
2006-10-18
Classification advisory
Ophthalmic
Review advisory
Obstetrics/Gynecology
Type
Post-NSE

Current FDA Classification#

Product code
NPB
Device name
System, Monitoring, For Progress Of Labor
Medical specialty
Ophthalmic
Device class
2
Regulation
884.2800
Implant
N
Life sustain/support
N