FDA 510(k) Application Details - K242304

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K242304
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	NeurAxis, Inc 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	876.1725   More FDA Info for this Regulation Number
Classification Product Code	KLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2024
Decision Date	12/06/2024
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