510(k) DEN170043

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

June 12, 2018

Date Received

August 17, 2017

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

Device Class

Class II

Regulation Number

862.1358

Review Panel

CH

Submission Type

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.