K222680 is an FDA 510(k) clearance for the DeltaScan Monitor. This device is classified as a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (Class II - Special Controls, product code NCG).
Submitted by Prolira B.V. (Utrecht, NL). The FDA issued a Cleared decision on February 2, 2023, 149 days after receiving the submission on September 6, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1440. 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.".
| 510(k) Number | K222680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2022 |
| Decision Date | February 02, 2023 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NCG - Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1440 |
| Definition | 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." |