FDA 510(k) Application Details - K243891

Device Classification Name	More FDA Info for this Device
510(K) Number	K243891
Device Name	EarliPoint System
Applicant	EarliTec Diagnostics 755 Commerce Drive, Suite 700 Decatur, GA 30030 US Other 510(k) Applications for this Company
Contact	Ryan Bormann Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2024
Decision Date	03/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review