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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeNPB
Regulation Number 884.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
BARNEV, LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2
TRIG MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

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