SAR

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

Product code
SAR
Device name
Adjunctive Hemodynamic Indicator With Decision Point For Military Use
Device class
Class 2
21 CFR
21 CFR 870.2220
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-05.

NumberDecision dateApplicantDevice nameSummary
K2332492024-04-05The Surgeon General, Department of the…APPRAISE-HRIPDF

1 summaries are archived here for direct download.

Official FDA classification page: SAR
Classification and pathway per current FDA publications. Data from openFDA (CC0).