Product code PYV

Device name

Hospital Continuous Glucose Monitoring System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1345

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.

Source

FDA openFDA device classification dataset