Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

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

Classification

FDA Product Code: QCC
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

An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 1

Source

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