510(k) K231824

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

October 18, 2023

Date Received

June 21, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Continuous Glucose Monitor Informed Insulin Dose Calculator

Device Class

Class II

Regulation Number

862.1358

Review Panel

CH

Submission Type

A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.