FDA 510(k) Application Details - K212593

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K212593
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	Biotronick, Inc. 6024 Jean Road Lake Oswego, OR 97035 US Other 510(k) Applications for this Company
Contact	Jon Brumbaugh 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	08/16/2021
Decision Date	10/15/2021
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