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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device image processing device for estimation of external blood loss
Regulation Description Image processing device for estimation of external blood loss.
Definition An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
Product CodePBZ
Regulation Number 880.2750
Device Class 2


Premarket Reviews
ManufacturerDecision
GAUSS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2


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