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Infrared Hematoma Detector

FDA product code OPT · 4 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 882.1935
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-01-11 – 2024-12-12

To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

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