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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adjunctive cardiovascular status indicator
Regulation Description Adjunctive cardiovascular status indicator.
Definition The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). 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 CodePPW
Regulation Number 870.2200
Device Class 2


Premarket Reviews
ManufacturerDecision
ETIOMETRY, INC.
  SUBSTANTIALLY EQUIVALENT 4
FLASHBACK TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROLAIO, INC.
  SUBSTANTIALLY EQUIVALENT 1

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