Product code QMS

Device name

Adjunctive Open Loop Fluid Therapy Recommender

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.5600

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Source

FDA openFDA device classification dataset