OMA
16 FDA 510(k) clearances · Product code
192 daysmedian time to decision
323 days90th percentile
16clearances measured
FDA profile
- Official device name
- Amplitude-Integrated Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- FDA definition
- Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
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Every clearance here is in the API, with alerts when new ones post.