Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-