NPB — System, Monitoring, For Progress Of Labor Class II
FDA product code NPB covers "System, Monitoring, For Progress Of Labor", a Class II medical device regulated under 21 CFR 884.2800. Submissions are reviewed by the Ophthalmic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NPB
- Device Class
- Class II
- Regulation Number
- 884.2800
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Ophthalmic
- Implant
- No
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.