FDA product code OPT
Infrared Hematoma Detector
Ophthalmic·Class 2·21 CFR 882.1935
US regulatory classifications
- US Product Code (FDA)
- OPTView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 882.1935View CFR Regulation →
- Medical specialty
- Ophthalmic
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
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About this record
Infrared Hematoma Detector is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.