FDA 510(k) Application Details - K233249

Device Classification Name	More FDA Info for this Device
510(K) Number	K233249
Device Name	APPRAISE-HRI
Applicant	The Surgeon General, Department of the Army (TSG-DA) U.S. Army Medical Materiel Research & Development Command; ATTN: FCMR-ORA, 1430 Veterans Drive Fort Dietrick, MD 21702-5009 US Other 510(k) Applications for this Company
Contact	Emily Badraslionglu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	04/05/2024
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