FDA 510(k) Application Details - K181864

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K181864
Device Name	Generator, Lesion, Radiofrequency
Applicant	Baylis Medical Company Inc. 2775 Matheson Blvd. East Mississauga L4W 4P7 CA Other 510(k) Applications for this Company
Contact	May Tsai Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2018
Decision Date	01/02/2019
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