FDA 510(k) Application Details - K221303

Device Classification Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K221303
Device Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant	Neuspera Medical Inc. 51 Daggett Dr. San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Alexander Yeh Other 510(k) Applications for this Contact
Regulation Number	882.5870   More FDA Info for this Regulation Number
Classification Product Code	GZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2022
Decision Date	04/11/2023
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