Device Classification Name |
neuropsychiatric interpretative electroencephalograph assessment aid
|
510(k) Number |
K222680 |
Device Name |
DeltaScan Monitor |
Applicant |
Prolira B.V. |
Padualaan 8 |
Utrecht,
NL
3584 CH
|
|
Applicant Contact |
Rutger O. van Merkerk |
Correspondent |
Corolla Clin/Reg Consulting |
481 Spindrift Trail #696 |
Corolla,
NC
23059
|
|
Correspondent Contact |
Paul J Manberg |
Regulation Number | 882.1440
|
Classification Product Code |
|
Date Received | 09/06/2022 |
Decision Date | 02/02/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03966274
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|