FDA 510(k) Application Details - K213697

Device Classification Name	Motor, Drill, Electric   More FDA Info for this Device
510(K) Number	K213697
Device Name	Motor, Drill, Electric
Applicant	Bien-Air Surgery SA Rue de l'Ouest 2b Le Noirmont 2340 CH Other 510(k) Applications for this Company
Contact	Jonas Guerdat Other 510(k) Applications for this Contact
Regulation Number	882.4360   More FDA Info for this Regulation Number
Classification Product Code	HBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2021
Decision Date	10/31/2022
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