Devices · DreaMed Diabetes Ltd

DreaMed Advisor Pro

DreaMed Diabetes Ltd is listed for DreaMed Advisor Pro (K191370). The FDA list gives July 18, 2019 as the date of the final decision. The lead panel is Clinical Chemistry, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QCC as “Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191370

Official FDA database record

Date of final decision

July 18, 2019

Company on the FDA list

DreaMed Diabetes Ltd

Lead panel

Clinical Chemistry

Primary product code

QCC

openFDA device name for the code

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Device class

2

Regulation number

862.1358

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary