510(k) K082704
K082704 is an FDA 510(k) premarket notification submitted by Barnev, Ltd. for the device "BIRTHTRACK (A.K.A. CLM)". The FDA issued a decision of Substantially Equivalent on January 9, 2009. 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
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2009
- Date Received
- September 16, 2008
- Clearance Type
- Traditional
- 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.