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System, Monitoring, For Progress Of Labor

FDA product code NPB · 3 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 884.2800
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-07-08 – 2009-03-04

This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.

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