FDA 510(k) Application Details - K203764

Device Classification Name	More FDA Info for this Device
510(K) Number	K203764
Device Name	TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Applicant	Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 US Other 510(k) Applications for this Company
Contact	Kristin Ellis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2020
Decision Date	03/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review