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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adjunctive heart failure status indicator
Regulation Description Adjunctive cardiovascular status indicator.
Definition The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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 CodeQUO
Regulation Number 870.2200
Device Class 2


Premarket Reviews
ManufacturerDecision
AVICENA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ULTROMICS LIMITED
  SUBSTANTIALLY EQUIVALENT 2

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