QCC

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Product code

QCC

Device name

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Device class

Class 2

21 CFR

21 CFR 862.1358

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-03.

1 summaries are archived here for direct download.