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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medium-term adjunctive predictive cardiovascular indicator
Regulation Description Adjunctive predictive cardiovascular indicator.
Definition The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Product CodeQNL
Regulation Number 870.2210
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILEMD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEW MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1

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