FDA product code NPB

System, Monitoring, For Progress Of Labor

Ophthalmic·Class 2·21 CFR 884.2800
US regulatory classifications
US Product Code (FDA)
NPB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 884.2800
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

System, Monitoring, For Progress Of Labor is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.