FDA 510(k) Application Details - K212355

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K212355
Device Name	Stimulator, Nerve
Applicant	Checkpoint Surgical 6050 Oak Tree Blvd., Suite 360 Independence, OH 44131 US Other 510(k) Applications for this Company
Contact	Ben Cottrill 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	07/29/2021
Decision Date	08/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review