Product code OPT
- Device name
- Infrared Hematoma Detector
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 882.1935
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
- Source
- FDA openFDA device classification dataset