FDA 510(k) Application Details - K233253

Device Classification Name	More FDA Info for this Device
510(K) Number	K233253
Device Name	eCARTv5 Clinical Deterioration Suite (ôeCARTö)
Applicant	AgileMD, Inc. 2261 Market Street #4378 San Francisco, CA 94114 US Other 510(k) Applications for this Company
Contact	Borna Safabakhsh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	06/21/2024
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