510(k) K233249

APPRAISE-HRI by The Surgeon General, Department of the Army (TSG-DA) — Product Code SAR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 5, 2024
Date Received: September 28, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Adjunctive Hemodynamic Indicator With Decision Point For Military Use
Device Class: Class II
Regulation Number: 870.2220
Review Panel: CV
Submission Type

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.