FDA 510(k) Application Details - K250451

Device Classification Name	More FDA Info for this Device
510(K) Number	K250451
Device Name	NeurAxis IB-Stim (01-1020)
Applicant	NeurAxis 11611 N. Meridian St. Suite 330 Carmel, IN 46032 US Other 510(k) Applications for this Company
Contact	Thomas Carrico Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2025
Decision Date	05/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review