← FDA Medical Device Classifications
Normalizing Quantitative Electroencephalograph Software
OLU · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1400
Classification
- FDA Product Code
OLU- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 882.1400
- Review panel
- NE
- Medical specialty
- Neurology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Market data
- Cleared 510(k) submissions
- 12
- Registered establishments
- 10
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown