510(k) K191370

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 18, 2019

Date Received

May 22, 2019

Clearance Type

Traditional

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.