Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

QDL · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1355

Classification

FDA Product Code: QDL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1355
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

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