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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adjunctive hemodynamic indicator with decision point
Regulation Description Adjunctive hemodynamic indicator with decision point.
Definition An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
Product CodeQNV
Regulation Number 870.2220
Device Class 2


Premarket Reviews
ManufacturerDecision
FIFTH EYE INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2

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