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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neonatal icu continuous non-invasive blood pressure monitor (includes alarms)
Definition The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring.
Product CodeQYF
Regulation Number 870.1130
Device Class 2

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