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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software device to aid in the prediction or diagnosis of sepsis
Definition A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.
Product CodeSAK
Regulation Number 880.6313
Device Class 2


Premarket Reviews
ManufacturerDecision
PRENOSIS, INC.
  GRANTED 1

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