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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name adjunctive hemodynamic indicator with decision point for military use
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
Applicant Contact Emily Badraslionglu
Correspondent
U.S. Army Medical Materiel Research & Development Command;
ATTN: FCMR-ORA,
1430 Veterans Drive
Fort Detrick,  MD  21702
Correspondent Contact Chandar Thakur
Regulation Number870.2220
Classification Product Code
SAR  
Date Received09/28/2023
Decision Date 04/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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