FDA 510(k) Application Details - K222680

Device Classification Name	More FDA Info for this Device
510(K) Number	K222680
Device Name	DeltaScan Monitor
Applicant	Prolira B.V. Padualaan 8 Utrecht 3584 CH NL Other 510(k) Applications for this Company
Contact	Rutger O. van Merkerk Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2022
Decision Date	02/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review