FDA 510(k) Application Details - K244056

Device Classification Name	Orthosis, Cranial, Laser Scan   More FDA Info for this Device
510(K) Number	K244056
Device Name	Orthosis, Cranial, Laser Scan
Applicant	Cranial Technologies, Inc. 1405 W Auto Dr, Floor 2 Tempe, AZ 85284 US Other 510(k) Applications for this Company
Contact	Jeff Riggs Other 510(k) Applications for this Contact
Regulation Number	882.5970   More FDA Info for this Regulation Number
Classification Product Code	OAN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2024
Decision Date	03/17/2025
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