FDA 510(k) Application Details - K231580

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K231580
Device Name	Stimulator, Nerve
Applicant	Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 US Other 510(k) Applications for this Company
Contact	Alexandra Oliver Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2023
Decision Date	08/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review