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Image Processing Device For Estimation Of External Blood Loss

FDA product code PBZ · 4 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.2750
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-08-05 – 2026-03-16

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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