FDA 510(k) Application Details - K210665

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K210665
Device Name	Cuff, Nerve
Applicant	BioCircuit Technologies, Incorporated 1819 Peachtree Road NE, STE 205 Atlanta, GA 30309 US Other 510(k) Applications for this Company
Contact	Jack Griffis Other 510(k) Applications for this Contact
Regulation Number	882.5275   More FDA Info for this Regulation Number
Classification Product Code	JXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2021
Decision Date	07/15/2022
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