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PBZ — Image Processing Device For Estimation Of External Blood Loss Class II

FDA Device Classification

Classification Details

Product Code
PBZ
Device Class
Class II
Regulation Number
880.2750
Submission Type
Review Panel
SU
Medical Specialty
General Hospital
Implant
No

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.

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