Product code QOG

Device name

Injection Data Capture Device

Medical specialty

General Hospital

Device class

2

Regulation number

880.5860

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.

Source

FDA openFDA device classification dataset