System, Monitoring, For Progress Of Labor
The labor progress monitoring system is an obstetric device that provides intrapartum measurement of cervical dilation, fetal head station, and other sentinel anatomical markers to adjunctively assist clinicians in following the progress of labor alongside other diagnostic information. It is classified as FDA Class 2 under regulation 884.2800, reviewed by the Obstetrics/Gynecology panel (though listed under Ophthalmic specialty, likely a data entry discrepancy), requiring 510(k) clearance. Product code NPB is not eligible for third-party review.
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Basic Information
- Product Code
- NPB
- Device Class
- FDA class 2
- Regulation Number
- 884.2800
- Medical Specialty
- Ophthalmic
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K081984 | LABORPRO SYSTEM | Mar 04, 2009 | Substantially Equivalent | Trig Medical, Ltd. |
| K082704 | BIRTHTRACK (A.K.A. CLM) | Jan 09, 2009 | Substantially Equivalent | Barnev, Ltd. |
| K080672 | BIRTHTRACK | Jul 08, 2008 | Substantially Equivalent | Barnev, Ltd. |
| DEN060006 | COMPUTERIZED LABOR MONITORING SYSTEM | Jan 30, 2007 | Unknown | Barnev, Ltd. |