510(k) DEN060006
DEN060006 is an FDA 510(k) premarket notification submitted by Barnev, Ltd. for the device "COMPUTERIZED LABOR MONITORING SYSTEM". The FDA issued a decision of De Novo Granted on January 30, 2007. The device falls under product code NPB (System, Monitoring, For Progress Of Labor), a Class II device regulated under 21 CFR 884.2800. Barnev, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 30, 2007
- Date Received
- October 18, 2006
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Monitoring, For Progress Of Labor
- Device Class
- Class II
- Regulation Number
- 884.2800
- Review Panel
- OB
- Submission Type
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.