FDA 510(k) Application Details - K230337

Device Classification Name	More FDA Info for this Device
510(K) Number	K230337
Device Name	EarliPoint
Applicant	EarliTec Diagnostics, Inc 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	02/07/2023
Decision Date	06/29/2023
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