Continuous Glucose Monitor Informed Insulin Dose Calculator

QRX · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1358

Classification

FDA Product Code: QRX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1358
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 2

Source

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