Devices · The Surgeon General, Department of the Army (TSG-DA)

APPRAISE-HRI

The Surgeon General, Department of the Army (TSG-DA) is listed for APPRAISE-HRI (K233249). The FDA list gives April 5, 2024 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SAR as “Adjunctive Hemodynamic Indicator With Decision Point For Military Use”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233249

Official FDA database record

Date of final decision

April 5, 2024

Company on the FDA list

The Surgeon General, Department of the Army (TSG-DA)

Lead panel

Cardiovascular

Primary product code

SAR

openFDA device name for the code

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

Device class

2

Regulation number

870.2220

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary