Injection Data Capture Device

QOG · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5860

Classification

FDA Product Code: QOG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5860
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 7

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown