FDA 510(k) Application Details - K190980

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K190980
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 US Other 510(k) Applications for this Company
Contact	Amanda Babcock 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	04/15/2019
Decision Date	07/01/2019
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