FDA 510(k) Application Details - DEN200018

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200018
Device Name	eXciteOSA with remote and eXciteOSA without remote
Applicant	Signifier Medical Technologies The Triangle, 6th Floor, Hammersmith Grove, Hammersmith London W6 0LG GB Other 510(k) Applications for this Company
Contact	Yasser Zayni Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2020
Decision Date	02/05/2021
Decision	DENG -
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review