Medical devices; reclassification and codification of home uterine activity monitor. Final rule.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D005260:Female; D006801:Humans; D007745:Labor Onset; D018670:Monitoring, Ambulatory / Q000145:classification* / Q000295:instrumentation; D011247:Pregnancy; D014481:United States; D014486:United States Food and Drug Administration; D014590:Uterine Contraction; D018590:Uterine Monitoring / Q000145:classification* / Q000295:instrumentation