← FDA Medical Device Classifications
Infrared Hematoma Detector
OPT · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 882.1935
Classification
- FDA Product Code
OPT- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 882.1935
- Review panel
- NE
- Medical specialty
- Ophthalmic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Market data
- Cleared 510(k) submissions
- 5
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown