FDA 510(k) Application Details - K203261

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K203261
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	Rick Ferreira 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	11/05/2020
Decision Date	03/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review