FDA 510(k) Application Details - K240948

Device Classification Name	More FDA Info for this Device
510(K) Number	K240948
Device Name	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Applicant	Imperative Care, Inc. 1359 Dell Ave 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	04/08/2024
Decision Date	06/06/2024
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