510(k) K222680
K222680 is an FDA 510(k) premarket notification submitted by Prolira B.V. for the device "DeltaScan Monitor". The FDA issued a decision of Substantially Equivalent on February 2, 2023. The device falls under product code NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid), a Class II device regulated under 21 CFR 882.1440. Prolira B.V. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2023
- Date Received
- September 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1440
- Review Panel
- NE
- Submission Type
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."