FDA 510(k) Application Details - K183649

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K183649
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	Baylis Medical Company Inc. 2580 Matheson Blvd. E Mississauga L4W 4J1 CA Other 510(k) Applications for this Company
Contact	Meghal Khakhar Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2018
Decision Date	06/07/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review