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U.S. Department of Health and Human Services

Product Classification

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Device system, monitoring, for progress of labor
Regulation Description Computerized Labor Monitoring System.
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.
Physical State 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.
Technical Method 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.
Target Area 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.
Regulation Medical Specialty Ophthalmic
Review Panel Obstetrics/Gynecology
Product CodeNPB
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
Third Party Review Not Third Party Eligible
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