510(k) K222680
- Device
- DeltaScan Monitor
- Applicant
- Prolira B.V.
- 510(k) number
- K222680
- Product code
- NCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-02
- Date received
- 2022-09-06
- Regulation
- 882.1440
- Classification name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rutger O. van Merkerk
- Address
- Padualaan 8 Utrecht NL 3584 CH 3584 CH
FDA Registration Numbers#
- 3013671918