Product code SAR

Device name

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.2220

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset